Study: NCT03640312

Adverse event: Road traffic accident
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Motor Vehicle Accident. Severity: Severe. Outcome: Resolved with sequelae. Blinded relatedness assessment: Unrelated. Investigational product action taken: Temporarily Withdrawn. Resulted in hospitalization.
Frequency: 1 affected / 32 at risk

Adverse event: Chest pain
Serious: yes
Organ System: General disorders
Notes: Severity: Severe. Outcome: Resolved with Sequelae. Relatedness Assessment: Unrelated. Investigational Product action taken: Temporarily Withdrawn. Resulted in hospitalization.
Frequency: 1 affected / 32 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Notes: 2 Total events:

1. Severity: Mild. Outcome: Ongoing at study exit. Relatedness assessment: Unrelated. Investigational product action taken: None. Study arm: Candesartan
2. Severe, resolved without sequelae, unlikely related, no action taken, LDQT
Frequency: 1 affected / 32 at risk

Adverse event: Tinnitus
Serious: no
Organ System: Ear and labyrinth disorders
Notes: Ringing in ears, mild, ongoing at study exit, assessed unrelated, no IP action taken.
Frequency: 1 affected / 32 at risk

Adverse event: Eye pruritis
Serious: no
Organ System: Eye disorders
Notes: Itchy eyes, mild, resolved without sequelae, unlikely relatedness, no IP action taken
Frequency: 1 affected / 32 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: 5 total events (2 control, 3 LDQT) Diarrhea, mild (5/5), resolved w/o sequelae (4/5) ongoing at study exit (1/5), unlikely (2/5) unrelated (3/5), no IP action taken (4/5) temporarily withdrawn (1/5).
Frequency: 3 affected / 32 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Notes: 3 total Stomach cramping (1/3) stomach gas/pain (2/3), mild (3/3), resolved without sequelae (2/3) ongoing at study exit (1/3), unrelated (3/3), no IP action taken (1/3) temporarily withdrawn (1/3) permanently discontinued (1/3)
Frequency: 1 affected / 32 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Notes: mild, resolved without sequelae, unrelated, no IP action taken
Frequency: 1 affected / 32 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Notes: mild, resolved without sequelae, unrelated, no IP action taken
Frequency: 1 affected / 32 at risk

Adverse event: Throat irritation
Serious: no
Organ System: Gastrointestinal disorders
Notes: mild, resolved without sequelae, possible relatedness, no IP action taken
Frequency: 1 affected / 32 at risk

Adverse event: Dry throat
Serious: no
Organ System: Gastrointestinal disorders
Notes: mild, resolved without sequelae, possible relatedness, temporarily withdrawn
Frequency: 1 affected / 32 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: Nausea/Vomiting, mild, resolved without sequelae, unrelated, temporarily withdrawn
Frequency: 1 affected / 32 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: 4 total mild (4/4), resolved without sequelae (4/4), unrelated (1/4) unlikely (2/4), possible (1/4), no IP action taken (4/4)
Frequency: 2 affected / 32 at risk

Adverse event: Peripheral swelling
Serious: no
Organ System: General disorders
Notes: 4 total Swelling of legs/ankles (2/4) swelling of hands/feet (2/4), mild (4/4), resolved without sequelae (3/4) ongoing at study exit (1/4), unrelated (2/4) possible (2/4), no IP action taken (3/4) permanently discontinued (1/4)
Frequency: 1 affected / 32 at risk

Adverse event: Chest pain
Serious: no
Organ System: General disorders
Notes: mild, resolved without sequelae, unrelated, no IP action taken
Frequency: 1 affected / 32 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Notes: mild, resolved without sequelae, possible relatedness, temporarily withdrawn
Frequency: 1 affected / 32 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Notes: Body aches, mild, resolved without sequelae, unrelated, temporarily withdrawn
Frequency: 1 affected / 32 at risk

Adverse event: Blood glucose increased
Serious: no
Organ System: Investigations
Notes: Elevated blood sugar, mild, ongoing at study exit, unlikely relatedness, no IP action taken
Frequency: 1 affected / 32 at risk

Adverse event: Heart rate irregular
Serious: no
Organ System: Investigations
Notes: 5 total irregular/fast heartbeat (5/5), mild (5/5), resolved without sequelae (4/5) ongoing at study exit (1/5), unrelated (2/5) unlikely (2/5) possible (1/5), no IP action taken (3/5) permanently discontinued (2/5)
Frequency: 2 affected / 32 at risk

Adverse event: Muscle cramps/spasms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: 2 total mild (1/2) severe (1/2), resolved without sequelae (2/2), unrelated (1/2) unlikely (1/2), no IP action taken (2/2)
Frequency: 1 affected / 32 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: 8 total mild (8/8), resolved without sequelae (7/8) ongoing at study exit (1/8), unrelated (4/8) unlikely (3/8) possible (1/8), no IP action taken (6/8) permanently discontinued (2/8)
Frequency: 5 affected / 32 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Notes: 2 total mild (2/2), resolved without sequelae (2/2), possible relatedness (2/2), no IP action taken (2/2)
Frequency: 2 affected / 32 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Nervous system disorders
Notes: Blurred vision/vision or hearing changes, mild, resolved without sequelae, unlikely relatedness, permanently discontinued
Frequency: 1 affected / 32 at risk

Adverse event: Hypoaesthesia
Serious: no
Organ System: Nervous system disorders
Notes: cold/tingling/numb hands/feet, mild, resolved without sequelae, unrelated, no IP action taken
Frequency: 1 affected / 32 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Notes: 3 total mild (3/3), resolved without sequelae (1/3) resolved with sequelae (1/3) ongoing at study exit (1/3), unrelated (2/3) possible (1/3), no IP action taken (3/3)
Frequency: 2 affected / 32 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: 6 total Breathing problems (6/6), mild (5/6) moderate (1/6), resolved without sequelae (3/6) resolved with sequelae (2/6) ongoing at study exit (1/6), unrelated (4/6) unlikely (2/6), no IP action taken (5/6) temporarily withdrawn (1/6)
Frequency: 3 affected / 32 at risk

Adverse event: Respiration abnormal
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Breathing problem, severe, resolved without sequelae, unlikely relatedness, no IP action taken
Frequency: 1 affected / 32 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 2 total Sweating (2/2), mild (2/2), resolved without sequelae (2/2), unrealted (2/2), no IP action taken (1/2) permanently discontinued (1/2)
Frequency: 1 affected / 32 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Rash, mild, resolved without sequelae, unlikely relatedness, no IP action taken
Frequency: 1 affected / 32 at risk

Adverse event: Dizziness
Serious: no
Organ System: Vascular disorders
Notes: 5 total Feeling faint/lightheadedness/falling (5/5), mild (4/5) moderate (1/5), resolved without sequelae (5/5), unlikely relatedness (2/5) possible (3/5), no IP action taken (5/5)
Frequency: 4 affected / 32 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Notes: 2 Total events:

1. Severity: Mild. Outcome: Ongoing at study exit. Relatedness assessment: Unrelated. Investigational product action taken: None. Study arm: Candesartan
2. Severe, resolved without sequelae, unlikely related, no action taken, LDQT
Frequency: 1 affected / 30 at risk

Adverse event: Palpitations
Serious: no
Organ System: Cardiac disorders
Notes: Palpitations, mild, resolved without sequelae, possible relatedness, no IP action taken.
Frequency: 1 affected / 30 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: 5 total events (2 control, 3 LDQT) Diarrhea, mild (5/5), resolved w/o sequelae (4/5) ongoing at study exit (1/5), unlikely (2/5) unrelated (3/5), no IP action taken (4/5) temporarily withdrawn (1/5).
Frequency: 2 affected / 30 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Notes: 3 total Stomach cramping (1/3) stomach gas/pain (2/3), mild (3/3), resolved without sequelae (2/3) ongoing at study exit (1/3), unrelated (3/3), no IP action taken (1/3) temporarily withdrawn (1/3) permanently discontinued (1/3)
Frequency: 2 affected / 30 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Nausea/vomiting, mild, resolved without sequelae, possible relatedness, permanently discontinued
Frequency: 1 affected / 30 at risk

Adverse event: Feeling hot
Serious: no
Organ System: General disorders
Notes: Feeling warm, moderate, resolved without sequelae, possible relatedness, permanently discontinued
Frequency: 1 affected / 30 at risk

Adverse event: Influenza like illness
Serious: no
Organ System: General disorders
Notes: Flu-like symptoms, moderate, ongoing at study exit, unrelated, no IP action taken
Frequency: 1 affected / 30 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: 4 total mild (4/4), resolved without sequelae (4/4), unrelated (1/4) unlikely (2/4), possible (1/4), no IP action taken (4/4)
Frequency: 1 affected / 30 at risk

Adverse event: Peripheral swelling
Serious: no
Organ System: General disorders
Notes: 4 total Swelling of legs/ankles (2/4) swelling of hands/feet (2/4), mild (4/4), resolved without sequelae (3/4) ongoing at study exit (1/4), unrelated (2/4) possible (2/4), no IP action taken (3/4) permanently discontinued (1/4)
Frequency: 3 affected / 30 at risk

Adverse event: Heart rate irregular
Serious: no
Organ System: Investigations
Notes: 5 total irregular/fast heartbeat (5/5), mild (5/5), resolved without sequelae (4/5) ongoing at study exit (1/5), unrelated (2/5) unlikely (2/5) possible (1/5), no IP action taken (3/5) permanently discontinued (2/5)
Frequency: 2 affected / 30 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: mild, ongoing at study exit, unlikely relatedness, no IP action taken
Frequency: 1 affected / 30 at risk

Adverse event: Muscle cramps/spasms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: 2 total mild (1/2) severe (1/2), resolved without sequelae (2/2), unrelated (1/2) unlikely (1/2), no IP action taken (2/2)
Frequency: 1 affected / 30 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: 8 total mild (8/8), resolved without sequelae (7/8) ongoing at study exit (1/8), unrelated (4/8) unlikely (3/8) possible (1/8), no IP action taken (6/8) permanently discontinued (2/8)
Frequency: 2 affected / 30 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Notes: 3 total mild (3/3), resolved without sequelae (1/3) resolved with sequelae (1/3) ongoing at study exit (1/3), unrelated (2/3) possible (1/3), no IP action taken (3/3)
Frequency: 1 affected / 30 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Cold symptoms, mild, ongoing at study exit, unrelated, no IP action taken
Frequency: 1 affected / 30 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: 3 total mild (3/3), resolved without sequelae (1/3) resolved with sequelae (1/3) ongoing at study exit (1/3), unrelated (2/3) unlikely (1/3), no IP action taken (3/3)
Frequency: 3 affected / 30 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: 6 total Breathing problems (6/6), mild (5/6) moderate (1/6), resolved without sequelae (3/6) resolved with sequelae (2/6) ongoing at study exit (1/6), unrelated (4/6) unlikely (2/6), no IP action taken (5/6) temporarily withdrawn (1/6)
Frequency: 2 affected / 30 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 2 total Sweating (2/2), mild (2/2), resolved without sequelae (2/2), unrealted (2/2), no IP action taken (1/2) permanently discontinued (1/2)
Frequency: 1 affected / 30 at risk

Adverse event: Dizziness
Serious: no
Organ System: Vascular disorders
Notes: 5 total Feeling faint/lightheadedness/falling (5/5), mild (4/5) moderate (1/5), resolved without sequelae (5/5), unlikely relatedness (2/5) possible (3/5), no IP action taken (5/5)
Frequency: 1 affected / 30 at risk