Skip to content
Triangle logo TriangleGet started
← Full study record

NCT03070392 · ADVERSE EVENTS

Adverse events

Safety and Efficacy of IMCgp100 Versus Investigator Choice in Advanced Uveal Melanoma · Source last updated 2026-03-17

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Adverse events occurred during the study; they are not necessarily caused by treatment. Serious events are not interchangeable with severe/grade 3–4 events. These safety populations may differ from efficacy populations.

Collection time frame
Approximately 36 months.
Other-event reporting threshold
5%

The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Tebentafusp

Tebentafusp administered at 20 mcg at Cycle 1 Day 1, 30 mcg at Cycle 1 Day 8, and 68 mcg at Cycle 1 Day 15 by IV infusion and weekly thereafter.

69 / 245245 / 24584 / 245
Investigator's Choice

1 of 3 Investigator's Choice options: Systemic Dacarbazine, Ipilimumab or Pembrolizumab. Dacarbazine: administered at 1,000 mg/m2 of body surface area IV infusion every 3 weeks until disease progression or unacceptable toxicity; Ipilimumab: administered at 3 mg/kg IV infusion over 90 minutes every 3 weeks for a total of 4 treatments; Pembrolizumab: administered at 2 mg/kg IV infusion up to a maximum of 200 mg administered Intravenously over 30 minutes every 3 weeks or 200 mg fixed dose administered intravenously every 3 weeks where approved locally until confirmed disease progression or unacceptable toxicity.

26 / 111102 / 11157 / 111

Group identifiers: EG000: Tebentafusp · EG001: Investigator's Choice

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      245
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      111
      num Events
      0
    term
    Anemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      245
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      111
      num Events
      1
    term
    Left ventricular dysfunction
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      245
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      111
      num Events
      1
    term
    Hypopituitarism
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      245
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      111
      num Events
      0
    term
    Diplopia
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      245
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      111
      num Events
      0
    term
    Periorbital edema
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      245
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      111
      num Events
      1
    term
    Uveitis
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      245
      num Events
      4
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      111
      num Events
      3
    term
    Abdominal pain
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      245
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      111
      num Events
      0
    term
    Abdominal pain upper
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      245
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      111
      num Events
      1
    term
    Colitis
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      245
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      111
      num Events
      1
    term
    Diarrhea
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      245
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      111
      num Events
      1
    term
    Enteritis
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      245
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      111
      num Events
      1
    term
    Gastritis

Other reported adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      25
      num At Risk
      245
      num Events
      62
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      111
      num Events
      4
    term
    Anemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      24
      num At Risk
      245
      num Events
      51
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      111
      num Events
      4
    term
    Lymphopenia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      245
      num Events
      7
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      111
      num Events
      10
    term
    Thrombocytopenia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      24
      num At Risk
      245
      num Events
      45
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      111
      num Events
      3
    term
    Tachycardia
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      245
      num Events
      2
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      111
      num Events
      16
    term
    Hyperthyroidism
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      245
      num Events
      3
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      111
      num Events
      15
    term
    Hypothyroidism
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      26
      num At Risk
      245
      num Events
      51
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      111
      num Events
      1
    term
    Periorbital edema
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      59
      num At Risk
      245
      num Events
      92
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      111
      num Events
      21
    term
    Abdominal pain
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      50
      num At Risk
      245
      num Events
      79
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      111
      num Events
      21
    term
    Abdominal pain upper
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      44
      num At Risk
      245
      num Events
      65
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      111
      num Events
      15
    term
    Constipation
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      61
      num At Risk
      245
      num Events
      120
    2. group Id
      EG001
      num Affected
      22
      num At Risk
      111
      num Events
      45
    term
    Diarrhea
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      245
      num Events
      9
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      111
      num Events
      6
    term
    Dry mouth
Complete source fields
description
The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.
event Groups
  1. deaths Num Affected
    84
    deaths Num At Risk
    245
    description
    Tebentafusp administered at 20 mcg at Cycle 1 Day 1, 30 mcg at Cycle 1 Day 8, and 68 mcg at Cycle 1 Day 15 by IV infusion and weekly thereafter.
    id
    EG000
    other Num Affected
    245
    other Num At Risk
    245
    serious Num Affected
    69
    serious Num At Risk
    245
    title
    Tebentafusp
  2. deaths Num Affected
    57
    deaths Num At Risk
    111
    description
    1 of 3 Investigator's Choice options: Systemic Dacarbazine, Ipilimumab or Pembrolizumab. Dacarbazine: administered at 1,000 mg/m2 of body surface area IV infusion every 3 weeks until disease progression or unacceptable toxicity; Ipilimumab: administered at 3 mg/kg IV infusion over 90 minutes every 3 weeks for a total of 4 treatments; Pembrolizumab: administered at 2 mg/kg IV infusion up to a maximum of 200 mg administered Intravenously over 30 minutes every 3 weeks or 200 mg fixed dose administered intravenously every 3 weeks where approved locally until confirmed disease progression or unacceptable toxicity.
    id
    EG001
    other Num Affected
    102
    other Num At Risk
    111
    serious Num Affected
    26
    serious Num At Risk
    111
    title
    Investigator's Choice
frequency Threshold
5
other Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      25
      num At Risk
      245
      num Events
      62
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      111
      num Events
      4
    term
    Anemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      24
      num At Risk
      245
      num Events
      51
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      111
      num Events
      4
    term
    Lymphopenia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      245
      num Events
      7
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      111
      num Events
      10
    term
    Thrombocytopenia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      24
      num At Risk
      245
      num Events
      45
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      111
      num Events
      3
    term
    Tachycardia
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      245
      num Events
      2
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      111
      num Events
      16
    term
    Hyperthyroidism
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      245
      num Events
      3
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      111
      num Events
      15
    term
    Hypothyroidism
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      26
      num At Risk
      245
      num Events
      51
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      111
      num Events
      1
    term
    Periorbital edema
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      59
      num At Risk
      245
      num Events
      92
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      111
      num Events
      21
    term
    Abdominal pain
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      50
      num At Risk
      245
      num Events
      79
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      111
      num Events
      21
    term
    Abdominal pain upper
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      44
      num At Risk
      245
      num Events
      65
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      111
      num Events
      15
    term
    Constipation
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      61
      num At Risk
      245
      num Events
      120
    2. group Id
      EG001
      num Affected
      22
      num At Risk
      111
      num Events
      45
    term
    Diarrhea
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      245
      num Events
      9
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      111
      num Events
      6
    term
    Dry mouth
serious Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      245
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      111
      num Events
      0
    term
    Anemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      245
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      111
      num Events
      1
    term
    Left ventricular dysfunction
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      245
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      111
      num Events
      1
    term
    Hypopituitarism
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      245
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      111
      num Events
      0
    term
    Diplopia
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      245
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      111
      num Events
      0
    term
    Periorbital edema
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      245
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      111
      num Events
      1
    term
    Uveitis
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      245
      num Events
      4
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      111
      num Events
      3
    term
    Abdominal pain
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      245
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      111
      num Events
      0
    term
    Abdominal pain upper
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      245
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      111
      num Events
      1
    term
    Colitis
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      245
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      111
      num Events
      1
    term
    Diarrhea
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      245
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      111
      num Events
      1
    term
    Enteritis
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      245
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      111
      num Events
      1
    term
    Gastritis
time Frame
Approximately 36 months.

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice