anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Gabapentin
Trial phase: Phase 3
ATC code: N02BF01 | N03AX12
SMILES: NCC1(CC(=O)O)CCCCC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 38
Group description: Gabapentin 300 mg capsule was taken orally with an initial dosage of 3 capsules per day divided into 3 doses with a time interval of 8 hours between each dose for one week; and then dose increased up to 3 weeks as per dosage adjustment schedule.
Eligibility criteria:
Inclusion Criteria:

Subjects diagnosed with diabetes mellitus type 2
Subjects with a history of neuropathic pain in the last 3 Months
Men and women in reproductive age with a family planning method
Subjects aged between 18 to 70 years
Subjects with glycosylated haemoglobin (HbA1c) greater than 7% and less than 15%
Subjects that obtain a grade equal or greater than 4 in the visual analogue scale during the screening visit

Exclusion Criteria:

Subjects diagnosed as being pregnant or in state of lactation
Subjects with serum creatinine greater than 1.2 or creatinine depuration in 24 hour urine, less than 60mL/min
Subjects who are receiving treatment with anti-depressants, anti-epileptics, and are taking vitamin B1 and B12 for treatment of neuropathic diabetes
Subjects who are being pharmacologically treated for epilepsy
Subjects diagnosed with rheumatic and hepatic disease and diagnosed with neuropathy for other causes
Subjects with psychological and psychiatric alteration that hinders adequate collaboration in the study
Subjects with any orthopaedic alteration of any extremity
Subjects with peripheral artery disease
Subjects taking more than two neuropathic pain medicines
Subjects with history of alcohol, cocaine, marijuana or benzodiazepine substance abuse
Subjects with acid-peptic disease
Subjects with history of neoplasm of any type
Intervention: Alogliptin
Trial phase: Phase 2
ATC code: A10BD09 | A10BD13 | A10BH04
SMILES: Cn1c(=O)cc(N2CCC[C@@H](N)C2)n(Cc2ccccc2C#N)c1=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 79
Group description: Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks.
Eligibility criteria:
Inclusion Criteria:

A glycosylated hemoglobin (HbA1c) value of 6.5% or more and below 10.0% 4 weeks after the start of screening(Week -4).
A HbA1c differences within 10.0%* (*rounded off to the first decimal point) at the start of screening (Week -8) and 4 weeks after the start of screening (Week -4) from the HbA1c value at the start of screening.
Was receiving a specific diet therapy and an exercise therapy (if any) for the last 4 weeks or longer before the start of screening (Week -8).

Exclusion Criteria:

Received any antidiabetic drug within the last 4 weeks before the start of screening (Week -8) or during screening.
Intervention: Alogliptin
Trial phase: Phase 2
ATC code: A10BD09 | A10BD13 | A10BH04
SMILES: Cn1c(=O)cc(N2CCC[C@@H](N)C2)n(Cc2ccccc2C#N)c1=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 84
Group description: Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.
Eligibility criteria:
Inclusion Criteria:

A glycosylated hemoglobin (HbA1c) value of 6.5% or more and below 10.0% 4 weeks after the start of screening(Week -4).
A HbA1c differences within 10.0%* (*rounded off to the first decimal point) at the start of screening (Week -8) and 4 weeks after the start of screening (Week -4) from the HbA1c value at the start of screening.
Was receiving a specific diet therapy and an exercise therapy (if any) for the last 4 weeks or longer before the start of screening (Week -8).

Exclusion Criteria:

Received any antidiabetic drug within the last 4 weeks before the start of screening (Week -8) or during screening.
Intervention: Alogliptin
Trial phase: Phase 2
ATC code: A10BD09 | A10BD13 | A10BH04
SMILES: Cn1c(=O)cc(N2CCC[C@@H](N)C2)n(Cc2ccccc2C#N)c1=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 80
Group description: Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.
Eligibility criteria:
Inclusion Criteria:

A glycosylated hemoglobin (HbA1c) value of 6.5% or more and below 10.0% 4 weeks after the start of screening(Week -4).
A HbA1c differences within 10.0%* (*rounded off to the first decimal point) at the start of screening (Week -8) and 4 weeks after the start of screening (Week -4) from the HbA1c value at the start of screening.
Was receiving a specific diet therapy and an exercise therapy (if any) for the last 4 weeks or longer before the start of screening (Week -8).

Exclusion Criteria:

Received any antidiabetic drug within the last 4 weeks before the start of screening (Week -8) or during screening.
Intervention: Alogliptin
Trial phase: Phase 2
ATC code: A10BD09 | A10BD13 | A10BH04
SMILES: Cn1c(=O)cc(N2CCC[C@@H](N)C2)n(Cc2ccccc2C#N)c1=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 79
Group description: Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks.
Eligibility criteria:
Inclusion Criteria:

A glycosylated hemoglobin (HbA1c) value of 6.5% or more and below 10.0% 4 weeks after the start of screening(Week -4).
A HbA1c differences within 10.0%* (*rounded off to the first decimal point) at the start of screening (Week -8) and 4 weeks after the start of screening (Week -4) from the HbA1c value at the start of screening.
Was receiving a specific diet therapy and an exercise therapy (if any) for the last 4 weeks or longer before the start of screening (Week -8).

Exclusion Criteria:

Received any antidiabetic drug within the last 4 weeks before the start of screening (Week -8) or during screening.
Intervention: Voglibose
Trial phase: Phase 2
ATC code: A10BF03
SMILES: OCC(CO)N[C@H]1C[C@](O)(CO)[C@@H](O)[C@H](O)[C@H]1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 83
Group description: Voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
Eligibility criteria:
Inclusion Criteria:

A glycosylated hemoglobin (HbA1c) value of 6.5% or more and below 10.0% 4 weeks after the start of screening(Week -4).
A HbA1c differences within 10.0%* (*rounded off to the first decimal point) at the start of screening (Week -8) and 4 weeks after the start of screening (Week -4) from the HbA1c value at the start of screening.
Was receiving a specific diet therapy and an exercise therapy (if any) for the last 4 weeks or longer before the start of screening (Week -8).

Exclusion Criteria:

Received any antidiabetic drug within the last 4 weeks before the start of screening (Week -8) or during screening.
Intervention: Voglibose
Trial phase: Phase 2 | Phase 3
ATC code: A10BF03
SMILES: OCC(CO)N[C@H]1C[C@](O)(CO)[C@@H](O)[C@H](O)[C@H]1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 75
Group description: Alogliptin placebo-matching tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
Eligibility criteria:
Inclusion Criteria:

Had been receiving a stable dose and regimen of an α-glucosidase inhibitor for the last 4 weeks or longer before the start of the screening phase (Week -8) and during the screening phase.
Had a glycosylated hemoglobin (HbA1c) value of 6.5% or more and below 10.0% 4 weeks after the start of the screening phase (Week -4).
Had HbA1c differences within 10.0% at the start of the screening phase (Week -8) and 4 weeks after the start of the screening phase (Week -4) from the HbA1c value at the start of the screening phase.
Was receiving a specific diet therapy and an exercise therapy (if any) for the last 4 weeks or longer before the start of the screening phase (Week -8).

Exclusion Criteria:

Had received any antidiabetic drug other than α-glucosidase inhibitors within the last 4 weeks before the start of the screening phase (Week -8) or during the screening phase.
Intervention: Alogliptin Benzoate
Trial phase: Phase 2 | Phase 3
SMILES: Cn1c(=O)cc(N2CCCC(N)C2)n(Cc2ccccc2C#N)c1=O.O=C(O)c1ccccc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 76
Group description: Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID
Eligibility criteria:
Inclusion Criteria:

Had been receiving a stable dose and regimen of an α-glucosidase inhibitor for the last 4 weeks or longer before the start of the screening phase (Week -8) and during the screening phase.
Had a glycosylated hemoglobin (HbA1c) value of 6.5% or more and below 10.0% 4 weeks after the start of the screening phase (Week -4).
Had HbA1c differences within 10.0% at the start of the screening phase (Week -8) and 4 weeks after the start of the screening phase (Week -4) from the HbA1c value at the start of the screening phase.
Was receiving a specific diet therapy and an exercise therapy (if any) for the last 4 weeks or longer before the start of the screening phase (Week -8).

Exclusion Criteria:

Had received any antidiabetic drug other than α-glucosidase inhibitors within the last 4 weeks before the start of the screening phase (Week -8) or during the screening phase.
Intervention: Alogliptin Benzoate
Trial phase: Phase 2 | Phase 3
SMILES: Cn1c(=O)cc(N2CCCC(N)C2)n(Cc2ccccc2C#N)c1=O.O=C(O)c1ccccc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 79
Group description: Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
Eligibility criteria:
Inclusion Criteria:

Had been receiving a stable dose and regimen of an α-glucosidase inhibitor for the last 4 weeks or longer before the start of the screening phase (Week -8) and during the screening phase.
Had a glycosylated hemoglobin (HbA1c) value of 6.5% or more and below 10.0% 4 weeks after the start of the screening phase (Week -4).
Had HbA1c differences within 10.0% at the start of the screening phase (Week -8) and 4 weeks after the start of the screening phase (Week -4) from the HbA1c value at the start of the screening phase.
Was receiving a specific diet therapy and an exercise therapy (if any) for the last 4 weeks or longer before the start of the screening phase (Week -8).

Exclusion Criteria:

Had received any antidiabetic drug other than α-glucosidase inhibitors within the last 4 weeks before the start of the screening phase (Week -8) or during the screening phase.
Intervention: Alogliptin
Trial phase: Phase 2
ATC code: A10BD09 | A10BD13 | A10BH04
SMILES: Cn1c(=O)cc(N2CCC[C@@H](N)C2)n(Cc2ccccc2C#N)c1=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 96
Group description: Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
Eligibility criteria:
Inclusion Criteria:

Had completed the phase 2 dose-ranging study (i.e., the subject had completed the study visit at Week 12).

Exclusion Criteria:

Had clinical manifestations of hepatic impairment (e.g., an aspartate aminotransferase or alanine aminotransferase value 2.5 times or more of the upper reference limit at Week 8 of treatment in the phase 2 dose-ranging study).
Had clinical manifestations of renal impairment (e.g., a creatinine value of 2 mg/dL or more at Week 8 of treatment in the phase 2 dose-ranging study).
Intervention: Alogliptin
Trial phase: Phase 2
ATC code: A10BD09 | A10BD13 | A10BH04
SMILES: Cn1c(=O)cc(N2CCC[C@@H](N)C2)n(Cc2ccccc2C#N)c1=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 101
Group description: Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
Eligibility criteria:
Inclusion Criteria:

Had completed the phase 2 dose-ranging study (i.e., the subject had completed the study visit at Week 12).

Exclusion Criteria:

Had clinical manifestations of hepatic impairment (e.g., an aspartate aminotransferase or alanine aminotransferase value 2.5 times or more of the upper reference limit at Week 8 of treatment in the phase 2 dose-ranging study).
Had clinical manifestations of renal impairment (e.g., a creatinine value of 2 mg/dL or more at Week 8 of treatment in the phase 2 dose-ranging study).
Intervention: Alogliptin
Trial phase: Phase 2
ATC code: A10BD09 | A10BD13 | A10BH04
SMILES: Cn1c(=O)cc(N2CCC[C@@H](N)C2)n(Cc2ccccc2C#N)c1=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 97
Group description: Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
Eligibility criteria:
Inclusion Criteria:

Had completed the phase 2 dose-ranging study (i.e., the subject had completed the study visit at Week 12).

Exclusion Criteria:

Had clinical manifestations of hepatic impairment (e.g., an aspartate aminotransferase or alanine aminotransferase value 2.5 times or more of the upper reference limit at Week 8 of treatment in the phase 2 dose-ranging study).
Had clinical manifestations of renal impairment (e.g., a creatinine value of 2 mg/dL or more at Week 8 of treatment in the phase 2 dose-ranging study).
Intervention: Alogliptin
Trial phase: Phase 2
ATC code: A10BD09 | A10BD13 | A10BH04
SMILES: Cn1c(=O)cc(N2CCC[C@@H](N)C2)n(Cc2ccccc2C#N)c1=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 97
Group description: Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
Eligibility criteria:
Inclusion Criteria:

Had completed the phase 2 dose-ranging study (i.e., the subject had completed the study visit at Week 12).

Exclusion Criteria:

Had clinical manifestations of hepatic impairment (e.g., an aspartate aminotransferase or alanine aminotransferase value 2.5 times or more of the upper reference limit at Week 8 of treatment in the phase 2 dose-ranging study).
Had clinical manifestations of renal impairment (e.g., a creatinine value of 2 mg/dL or more at Week 8 of treatment in the phase 2 dose-ranging study).
Intervention: Voglibose
Trial phase: Phase 2 | Phase 3
ATC code: A10BF03
SMILES: OCC(CO)N[C@H]1C[C@](O)(CO)[C@@H](O)[C@H](O)[C@H]1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 108
Group description: Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
Eligibility criteria:
Inclusion Criteria:

Had completed the phase 2 dose-ranging study (i.e., the subject had completed the study visit at Week 12).

Exclusion Criteria:

Had clinical manifestations of hepatic impairment (e.g., an aspartate aminotransferase or alanine aminotransferase value 2.5 times or more of the upper reference limit at Week 8 of treatment in the phase 2 dose-ranging study).
Had clinical manifestations of renal impairment (e.g., a creatinine value of 2 mg/dL or more at Week 8 of treatment in the phase 2 dose-ranging study).
Intervention: Voglibose
Trial phase: Phase 2 | Phase 3
ATC code: A10BF03
SMILES: OCC(CO)N[C@H]1C[C@](O)(CO)[C@@H](O)[C@H](O)[C@H]1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 105
Group description: Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
Eligibility criteria:
Inclusion Criteria:

Had completed the phase 2 dose-ranging study (i.e., the subject had completed the study visit at Week 12).

Exclusion Criteria:

Had clinical manifestations of hepatic impairment (e.g., an aspartate aminotransferase or alanine aminotransferase value 2.5 times or more of the upper reference limit at Week 8 of treatment in the phase 2 dose-ranging study).
Had clinical manifestations of renal impairment (e.g., a creatinine value of 2 mg/dL or more at Week 8 of treatment in the phase 2 dose-ranging study).
Intervention: Egrifta
Trial phase: Not Applicable
ATC code: H01AC06
SMILES: CCC=CCC(=O)NC(Cc1ccc(O)cc1)C(=O)NC(C)C(=O)NC(CC(=O)O)C(=O)NC(C)C(=O)NC(C(=O)NC(Cc1ccccc1)C(=O)NC(C(=O)NC(CC(N)=O)C(=O)NC(CO)C(=O)NC(Cc1ccc(O)cc1)C(=O)NC(CCCNC(=N)N)C(=O)NC(CCCCN)C(=O)NC(C(=O)NC(CC(C)C)C(=O)NCC(=O)NC(CCC(N)=O)C(=O)NC(CC(C)C)C(=O)NC(CO)C(=O)NC(C)C(=O)NC(CCCNC(=N)N)C(=O)NC(CCCCN)C(=O)NC(CC(C)C)C(=O)NC(CC(C)C)C(=O)NC(CCC(N)=O)C(=O)NC(CC(=O)O)C(=O)NC(C(=O)NC(CCSC)C(=O)NC(CO)C(=O)NC(CCCNC(=N)N)C(=O)NC(CCC(N)=O)C(=O)NC(CCC(N)=O)C(=O)NCC(=O)NC(CCC(=O)O)C(=O)NC(CO)C(=O)NC(CC(N)=O)C(=O)NC(CCC(N)=O)C(=O)NC(CCC(=O)O)C(=O)NC(CCCNC(=N)N)C(=O)NCC(=O)NC(C)C(=O)NC(CCCNC(=N)N)C(=O)NC(C)C(=O)NC(CCCNC(=N)N)C(=O)NC(CC(C)C)C(N)=O)C(C)CC)C(C)C)C(C)O)C(C)CC
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 28
Group description: Tesamorelin (growth hormone releasing hormone) 2mg daily given subcutaneously x 6 months during randomized phase, followed by 6 months of open-label tesamorelin at same dose
Eligibility criteria:
Inclusion Criteria:

Men and women age 18-65
Previously diagnosed HIV infection
Stable antiviral regimen for at least 12 weeks prior to enrollment
WC>95 cm and WHR>0.94 for male, WC>94 cm and WHR>0.88 for female occurring in the context of treatment for HIV disease
Subjective evidence of at least one of the following recent changes, occurring during the treatment of HIV disease: increased abdominal girth, relative loss of fat in the extremities, or relative loss of fat in the face
For female subjects 40yo or older, negative mammogram within one year of baseline

Exclusion Criteria:

Use of anti-diabetic agents, Megace, testosterone or any steroid use within 6 months of the study. Stable use of testosterone (> 6 mos) at dose equivalent to 200 mg IM q 2 weeks or < 10g/day to skin will be permitted.
Use of GH or GHRH within the past 6 months
Change in lipid lowering or antihypertensive regimen within 3 months of screening
Fasting blood sugar > 126 mg/dL, SGOT > 2.5 times ULN, HgB < 12.0 g/dL, creatinine > 1.4 mg/dL, CD4 count < 200
Severe chronic illness or active malignancy or history of pituitary malignancy or history of colon cancer
For men, history of prostate cancer or evidence of prostate malignancy by PSA > 5 ng/mL
Prior history of hypopituitarism, head irradiation or any other condition known to affect the GH axis
For women, positive urine hCG
Oral contraceptives, depo provera or combined progesterone-estrogen injections, transdermal contraceptive patches, estrogen or progestin coated IUD's within 6 months of the study.
Routine MRI exclusion criteria such as the presence of a pacemaker or cerebral aneurysm clip.
Intervention: Atorvastatin
Trial phase: Phase 4
ATC code: C10AA05 | C10BA05 | C10BX03 | C10BX06 | C10BX08 | C10BX11 | C10BX12 | C10BX15 | C10BX18 | C10BX19
SMILES: CC(C)c1c(C(=O)Nc2ccccc2)c(-c2ccccc2)c(-c2ccc(F)cc2)n1CC[C@@H](O)C[C@@H](O)CC(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 5
Group description: Atorvastatin: For subjects on PI-based HAART therapy: 10mg/day X 2weeks followed by 20mg/day.

For subjects on non PI-based HAART therapy: 20mg/day X 2weeks followed by 40mg/day.
Eligibility criteria:
Inclusion Criteria:

Chronic HIV-1 infected individuals presently on HAART with no change in drug combination for at least 3 months at time of enrollment
Plasma viral load <200 copies / ml for at least 6 months prior to enrollment in the study
CD4 T cell count more than 350/ul
Willingness to use a method of contraception during the study period
Willingness to have blood drawn
If female, willingness to undergo pregnancy testing on a monthly basis and are not breastfeeding
Ability to understand and willingness to sign the informed consent
hs-CRP levels above the upper limit of normal (>3mg/L)

Exclusion Criteria:

Concomitant use of fibric acid derivatives or other lipid lowering agents including patients on statins and Ezetimibe
Use of any anti-inflammatory drugs (OTC or prescription) on a daily basis
Pregnancy or breast feeding
Active drug use or alcohol abuse/dependence, which in the opinion of the investigators will interfere with the patient's ability to participate in the study
Allergy or hypersensitivity to statins or any of its components
History of myositis or rhabdomyolysis with use of any statins
Patients who are on concurrent immunomodulatory agents, including systemic corticosteroids will be ineligible for 3 months after completion of therapy with the immunomodulating agents
History of inflammatory muscle disease such as poly or dermatomyositis
Serious intercurrent illness requiring systemic treatment and/or hospitalization within 30 days of entry
Evidence of active opportunistic infections requiring treatment or neoplasms that require chemotherapy during the study period
Creatine phosphokinase elevations (CPK) greater than 3 times the upper limit of normal
Known active liver disease or AST/ALT greater than 2x the upper limit of normal
Renal insufficiency, indicated by serum creatinine 2 mg/dl
Absolute neutrophil count (ANC) 1000/mm3, hemoglobin < 10.0 g/dL for males and <9 g/dL for females, platelet count 100,000/mm
Intervention: Tapentadol
Trial phase: Phase 3
ATC code: N02AX06
SMILES: CC[C@@H](c1cccc(O)c1)[C@@H](C)CN(C)C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 31
Group description: All participants from the KF5503/15 that enrolled into this trial were on tapentadol prolonged release. Participants were dosed in the range of 100 to 250 mg tapentadol twice daily. The dose was titrated to achieve sufficient pain relief to continue with effective analgesia for as long as the participant tolerated and wishes to continue treatment.
Eligibility criteria:
Inclusion Criteria:

Participants must have signed an Informed Consent Form.
At least 18 years of age.
Male and non-pregnant, non-lactating female subjects. Sexually active women must be post menopausal, surgically sterile, or practicing an effective method of birth control before entry and throughout the trial. Female participants of child-bearing potential must have a negative pregnancy test at enrollment.
Within 24 weeks of either full completion or completion of the double-blind treatment period (Visit 8) of KF5503/15 trial performed in participants with moderate to severe chronic malignant tumor related pain.
Participant is, in the opinion of the investigator, expected to continue to have an overall positive benefit/risk ratio from continuing analgesic treatment within this trial.
Participant must be willing to take tapentadol prolonged release (PR) throughout their participation in the trial.

Exclusion Criteria:

History of alcohol and/or drug abuse.
The participant has a clinically significant disease other than cancer that in the Investigator's opinion may affect the safety of the participant.
Employees of the investigator or trial center or family members of the employees or the investigator.
Known to or suspected of not being able to comply with the protocol and the use of tapentadol prolonged release (PR).
Concurrent participation in another trial (except for participation in the KF5503/15 trial) or planning to be enrolled in another clinical trial during the course of this trial.
Previous participation in another trial between the end of KF5503/15 and enrollment into the current trial, KF5503/52.
History of seizure disorder, epilepsy, traumatic brain injury, stroke or transient ischemic attack.
Known history and/or presence of cerebral tumors or metastases.
Rapidly escalating pain or pain uncontrolled by therapy and was previously treated with maximum dose level of Investigational Medicinal Product.
Participant is taking any prohibited concomitant medications.
Uncontrolled hypertension.
Known moderate or severe hepatic impairment.
Known severe renal impairment.
Clinically relevant history of hypersensitivity, allergy, or contraindications to tapentadol or its excipients.