Study: NCT04320823

Adverse event: IQPP 9.1 Other
Serious: no
Organ System: Nervous system disorders
Notes: A reaction that does not fall into any other IQPP category. In this event, donor reported feeling dizzy during standard screening, prior to any plasmapheresis or study activities.
Frequency: 1 affected / 1717 at risk

Adverse event: IQPP 8.1 Hyperventilation
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: May include Anxiousness / Anxiety; Carpopedal Spasms; Chest Tightness; Dry Mouth; Paresthesia (Perioral -Tingling/Numbness); Paresthesia (Peripheral - Hands/Feet); Respiration, Rapid; Restlessness; Shaking; Shortness of Breath; or Tetany.
Frequency: 1 affected / 1717 at risk

Adverse event: IQPP 7.1 Allergic: Local
Serious: no
Organ System: Immune system disorders
Notes: May include Itching; Rash/Hives; or Redness.
Frequency: 3 affected / 1717 at risk

Adverse event: IQPP 4.2 Citrate Reaction: Moderate
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: May include Carpopedal Spasms; Chest Pressure; Cold Extremities; Chills; Muscle Tightness/Cramping; Nausea; Pallor, Pale Skin or Lips; Shortness of Breath; Sneezing/Nasal Congestion; Tetany (Transient); Tremors; Twitching; or Vomiting.
Frequency: 1 affected / 1717 at risk

Adverse event: IQPP 4.1 Citrate Reaction: Minor
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: May include Metallic Taste; Paresthesia (Perioral - Lips (Tingling/Numbness); or Paresthesia (Peripheral - Hands/Feet Tingling/Numbness).
Frequency: 2 affected / 1717 at risk

Adverse event: IQPP 3.3 Local Injury Related to Phlebotomy: Hematoma/Bruise (complicated)
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: May include Paresthesias, Numbness/Tingling of Fingers, Hand, or Arm; Pressure; Redness; Restricted Movement; Shooting Pain Down Arm; Significant Pain; Skin Discoloration; Swelling; Tenderness; Warmth; or Weakness of Arm.
Frequency: 12 affected / 1717 at risk

Adverse event: 3.1 Local Injury Related to Phlebotomy: Nerve Irritation
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: May include Immediate Intense Pain at Site; Paresthesias, Numbness/Tingling of Fingers, Hand, or Arm; Shooting Pain Down Arm; or Weakness of Arm.
Frequency: 1 affected / 1717 at risk

Adverse event: IQPP 1.5 Hypotensive (Vasovagal/Hypovolemia); Severe (With or Without LOC)
Serious: no
Organ System: Vascular disorders
Notes: This reaction may or may not include LOC and may include Chest Pain, Convulsions/Seizures, Loss of Bladder/Bowel
Frequency: 1 affected / 1717 at risk

Adverse event: IQPP 1.3 Hypotensive: LOC (brief)
Serious: no
Organ System: Vascular disorders
Notes: In this reaction, LOC lasts approximately less than sixty seconds.
Frequency: 1 affected / 1717 at risk

Adverse event: IQPP 1.2 Hypotensive: Prefaint, No LOC (Moderate):
Serious: no
Organ System: Vascular disorders
Notes: This reaction includes vomiting.
Frequency: 2 affected / 1717 at risk

Adverse event: IQPP 1.1 Hypotensive: Prefaint, No LOC (Minor)
Serious: no
Organ System: Vascular disorders
Notes: May include one or more of minor symptoms, e.g., abdominal cramps, auditory disturbance, chills or shivering, clammy, cold extremities, dizziness, nausea, sweating, weakness.
Frequency: 56 affected / 1717 at risk

Adverse event: IQPP 7.1 Allergic: Local
Serious: no
Organ System: Immune system disorders
Notes: May include Itching; Rash/Hives; or Redness.
Frequency: 5 affected / 1726 at risk

Adverse event: IQPP 4.1 Citrate Reaction: Minor
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: May include Metallic Taste; Paresthesia (Perioral - Lips (Tingling/Numbness); or Paresthesia (Peripheral - Hands/Feet Tingling/Numbness).
Frequency: 3 affected / 1726 at risk

Adverse event: IQPP 3.3 Local Injury Related to Phlebotomy: Hematoma/Bruise (complicated)
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: May include Paresthesias, Numbness/Tingling of Fingers, Hand, or Arm; Pressure; Redness; Restricted Movement; Shooting Pain Down Arm; Significant Pain; Skin Discoloration; Swelling; Tenderness; Warmth; or Weakness of Arm.
Frequency: 16 affected / 1726 at risk

Adverse event: IQPP 3.2 Local Injury Related to Phlebotomy: Hematoma/Bruise (uncomplicated)
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: May include Mild Pain; No Restriction of Movement; Skin Discoloration; or Swelling.
Frequency: 1 affected / 1726 at risk

Adverse event: 3.1 Local Injury Related to Phlebotomy: Nerve Irritation
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: May include Immediate Intense Pain at Site; Paresthesias, Numbness/Tingling of Fingers, Hand, or Arm; Shooting Pain Down Arm; or Weakness of Arm.
Frequency: 3 affected / 1726 at risk

Adverse event: IQPP 1.5 Hypotensive (Vasovagal/Hypovolemia); Severe (With or Without LOC)
Serious: no
Organ System: Vascular disorders
Notes: This reaction may or may not include LOC and may include Chest Pain, Convulsions/Seizures, Loss of Bladder/Bowel
Frequency: 1 affected / 1726 at risk

Adverse event: IQPP 1.4 Hypotensive (Vasovagal/Hypovolemia): LOC (prolonged)
Serious: no
Organ System: Vascular disorders
Notes: In this reaction, LOC lasts approximately sixty seconds or longer.
Frequency: 1 affected / 1726 at risk

Adverse event: IQPP 1.3 Hypotensive: LOC (brief)
Serious: no
Organ System: Vascular disorders
Notes: In this reaction, LOC lasts approximately less than sixty seconds.
Frequency: 1 affected / 1726 at risk

Adverse event: IQPP 1.2 Hypotensive: Prefaint, No LOC (Moderate):
Serious: no
Organ System: Vascular disorders
Notes: This reaction includes vomiting.
Frequency: 3 affected / 1726 at risk

Adverse event: IQPP 1.1 Hypotensive: Prefaint, No LOC (Minor)
Serious: no
Organ System: Vascular disorders
Notes: May include one or more of minor symptoms, e.g., abdominal cramps, auditory disturbance, chills or shivering, clammy, cold extremities, dizziness, nausea, sweating, weakness.
Frequency: 38 affected / 1726 at risk