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NCT01667419 · ADVERSE EVENTS

Adverse events

A Study of Vemurafenib Adjuvant Therapy in Participants With Surgically Resected Cutaneous BRAF-Mutant Melanoma · Source last updated 2019-07-23

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
Up to the data cutoff of July 13, 2018 (approximately 6 years).
Other-event reporting threshold
5%

The safety population included all participants who received at least one dose of study medication.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Cohort 1 Vemurafenib

Participants with completely resected Stage IIC, IIIA, or IIIB cutaneous melanoma) received vemurafenib, 960 mg twice daily, in 28-day cycles, for up to 52 weeks

25 / 154150 / 15418 / 154
Cohort 1 Placebo

Participants with completely resected Stage IIC, IIIA, or IIIB cutaneous melanoma) received vemurafenib-matching placebo twice daily, in 28-day cycles, for up to 52 weeks

16 / 156117 / 15633 / 156
Cohort 2 Vemurafenib

Participants with Stage IIIC cutaneous melanoma received vemurafenib, 960 mg twice daily, in 28-day cycles, for up to 52 weeks

15 / 9392 / 9325 / 93
Cohort 2 Placebo

Participants with Stage IIIC cutaneous melanoma received vemurafenib-matching placebo twice daily, in 28-day cycles, for up to 52 weeks

9 / 9167 / 9126 / 91

Group identifiers: EG000: Cohort 1 Vemurafenib · EG001: Cohort 1 Placebo · EG002: Cohort 2 Vemurafenib · EG003: Cohort 2 Placebo

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
    Cardiac disorders
    source Vocabulary
    MedDRA, Version 19.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      154
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      156
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      93
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      91
    term
    Pericarditis
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA, Version 19.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      154
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      156
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      93
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      91
    term
    Vertigo positional
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA, Version 19.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      154
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      156
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      93
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      91
    term
    Leukoplakia oral
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA, Version 19.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      154
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      156
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      93
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      91
    term
    Pancreatitis
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA, Version 19.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      154
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      156
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      93
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      91
    term
    Pancreatitis acute
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA, Version 19.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      154
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      156
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      93
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      91
    term
    Chest pain
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    MedDRA, Version 19.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      154
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      156
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      93
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      91
    term
    Bile duct stone
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA, Version 19.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      154
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      156
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      93
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      91
    term
    Appendicitis
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA, Version 19.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      154
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      156
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      93
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      91
    term
    Bronchitis
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA, Version 19.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      154
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      156
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      93
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      91
    term
    Cellulitis
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA, Version 19.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      154
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      156
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      93
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      91
    term
    Groin infection
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA, Version 19.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      154
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      156
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      93
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      91
    term
    Hepatitis B

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
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA, Version 19.1
    stats
    1. group Id
      EG000
      num Affected
      57
      num At Risk
      154
    2. group Id
      EG001
      num Affected
      20
      num At Risk
      156
    3. group Id
      EG002
      num Affected
      34
      num At Risk
      93
    4. group Id
      EG003
      num Affected
      10
      num At Risk
      91
    term
    Rash
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA, Version 19.1
    stats
    1. group Id
      EG000
      num Affected
      57
      num At Risk
      154
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      156
    3. group Id
      EG002
      num Affected
      37
      num At Risk
      93
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      91
    term
    Alopecia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA, Version 19.1
    stats
    1. group Id
      EG000
      num Affected
      44
      num At Risk
      154
    2. group Id
      EG001
      num Affected
      27
      num At Risk
      156
    3. group Id
      EG002
      num Affected
      28
      num At Risk
      93
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      91
    term
    Pruritus
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA, Version 19.1
    stats
    1. group Id
      EG000
      num Affected
      52
      num At Risk
      154
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      156
    3. group Id
      EG002
      num Affected
      35
      num At Risk
      93
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      91
    term
    Hyperkeratosis
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA, Version 19.1
    stats
    1. group Id
      EG000
      num Affected
      58
      num At Risk
      154
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      156
    3. group Id
      EG002
      num Affected
      25
      num At Risk
      93
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      91
    term
    Photosensitivity reaction
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA, Version 19.1
    stats
    1. group Id
      EG000
      num Affected
      32
      num At Risk
      154
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      156
    3. group Id
      EG002
      num Affected
      16
      num At Risk
      93
    4. group Id
      EG003
      num Affected
      5
      num At Risk
      91
    term
    Dry skin
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA, Version 19.1
    stats
    1. group Id
      EG000
      num Affected
      20
      num At Risk
      154
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      156
    3. group Id
      EG002
      num Affected
      17
      num At Risk
      93
    4. group Id
      EG003
      num Affected
      6
      num At Risk
      91
    term
    Erythema
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA, Version 19.1
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      154
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      156
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      93
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      91
    term
    Actinic keratosis
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA, Version 19.1
    stats
    1. group Id
      EG000
      num Affected
      101
      num At Risk
      154
    2. group Id
      EG001
      num Affected
      37
      num At Risk
      156
    3. group Id
      EG002
      num Affected
      49
      num At Risk
      93
    4. group Id
      EG003
      num Affected
      17
      num At Risk
      91
    term
    Arthralgia
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA, Version 19.1
    stats
    1. group Id
      EG000
      num Affected
      31
      num At Risk
      154
    2. group Id
      EG001
      num Affected
      15
      num At Risk
      156
    3. group Id
      EG002
      num Affected
      17
      num At Risk
      93
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      91
    term
    Pain in extremity
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA, Version 19.1
    stats
    1. group Id
      EG000
      num Affected
      23
      num At Risk
      154
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      156
    3. group Id
      EG002
      num Affected
      9
      num At Risk
      93
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      91
    term
    Myalgia
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA, Version 19.1
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      154
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      156
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      93
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      91
    term
    Musculoskeletal pain
Complete source fields
description
The safety population included all participants who received at least one dose of study medication.
event Groups
  1. deaths Num Affected
    18
    deaths Num At Risk
    154
    description
    Participants with completely resected Stage IIC, IIIA, or IIIB cutaneous melanoma) received vemurafenib, 960 mg twice daily, in 28-day cycles, for up to 52 weeks
    id
    EG000
    other Num Affected
    150
    other Num At Risk
    154
    serious Num Affected
    25
    serious Num At Risk
    154
    title
    Cohort 1 Vemurafenib
  2. deaths Num Affected
    33
    deaths Num At Risk
    156
    description
    Participants with completely resected Stage IIC, IIIA, or IIIB cutaneous melanoma) received vemurafenib-matching placebo twice daily, in 28-day cycles, for up to 52 weeks
    id
    EG001
    other Num Affected
    117
    other Num At Risk
    156
    serious Num Affected
    16
    serious Num At Risk
    156
    title
    Cohort 1 Placebo
  3. deaths Num Affected
    25
    deaths Num At Risk
    93
    description
    Participants with Stage IIIC cutaneous melanoma received vemurafenib, 960 mg twice daily, in 28-day cycles, for up to 52 weeks
    id
    EG002
    other Num Affected
    92
    other Num At Risk
    93
    serious Num Affected
    15
    serious Num At Risk
    93
    title
    Cohort 2 Vemurafenib
  4. deaths Num Affected
    26
    deaths Num At Risk
    91
    description
    Participants with Stage IIIC cutaneous melanoma received vemurafenib-matching placebo twice daily, in 28-day cycles, for up to 52 weeks
    id
    EG003
    other Num Affected
    67
    other Num At Risk
    91
    serious Num Affected
    9
    serious Num At Risk
    91
    title
    Cohort 2 Placebo
frequency Threshold
5
other Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA, Version 19.1
    stats
    1. group Id
      EG000
      num Affected
      57
      num At Risk
      154
    2. group Id
      EG001
      num Affected
      20
      num At Risk
      156
    3. group Id
      EG002
      num Affected
      34
      num At Risk
      93
    4. group Id
      EG003
      num Affected
      10
      num At Risk
      91
    term
    Rash
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA, Version 19.1
    stats
    1. group Id
      EG000
      num Affected
      57
      num At Risk
      154
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      156
    3. group Id
      EG002
      num Affected
      37
      num At Risk
      93
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      91
    term
    Alopecia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA, Version 19.1
    stats
    1. group Id
      EG000
      num Affected
      44
      num At Risk
      154
    2. group Id
      EG001
      num Affected
      27
      num At Risk
      156
    3. group Id
      EG002
      num Affected
      28
      num At Risk
      93
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      91
    term
    Pruritus
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA, Version 19.1
    stats
    1. group Id
      EG000
      num Affected
      52
      num At Risk
      154
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      156
    3. group Id
      EG002
      num Affected
      35
      num At Risk
      93
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      91
    term
    Hyperkeratosis
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA, Version 19.1
    stats
    1. group Id
      EG000
      num Affected
      58
      num At Risk
      154
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      156
    3. group Id
      EG002
      num Affected
      25
      num At Risk
      93
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      91
    term
    Photosensitivity reaction
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA, Version 19.1
    stats
    1. group Id
      EG000
      num Affected
      32
      num At Risk
      154
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      156
    3. group Id
      EG002
      num Affected
      16
      num At Risk
      93
    4. group Id
      EG003
      num Affected
      5
      num At Risk
      91
    term
    Dry skin
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA, Version 19.1
    stats
    1. group Id
      EG000
      num Affected
      20
      num At Risk
      154
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      156
    3. group Id
      EG002
      num Affected
      17
      num At Risk
      93
    4. group Id
      EG003
      num Affected
      6
      num At Risk
      91
    term
    Erythema
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA, Version 19.1
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      154
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      156
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      93
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      91
    term
    Actinic keratosis
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA, Version 19.1
    stats
    1. group Id
      EG000
      num Affected
      101
      num At Risk
      154
    2. group Id
      EG001
      num Affected
      37
      num At Risk
      156
    3. group Id
      EG002
      num Affected
      49
      num At Risk
      93
    4. group Id
      EG003
      num Affected
      17
      num At Risk
      91
    term
    Arthralgia
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA, Version 19.1
    stats
    1. group Id
      EG000
      num Affected
      31
      num At Risk
      154
    2. group Id
      EG001
      num Affected
      15
      num At Risk
      156
    3. group Id
      EG002
      num Affected
      17
      num At Risk
      93
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      91
    term
    Pain in extremity
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA, Version 19.1
    stats
    1. group Id
      EG000
      num Affected
      23
      num At Risk
      154
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      156
    3. group Id
      EG002
      num Affected
      9
      num At Risk
      93
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      91
    term
    Myalgia
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA, Version 19.1
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      154
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      156
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      93
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      91
    term
    Musculoskeletal pain
serious Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA, Version 19.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      154
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      156
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      93
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      91
    term
    Pericarditis
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA, Version 19.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      154
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      156
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      93
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      91
    term
    Vertigo positional
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA, Version 19.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      154
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      156
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      93
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      91
    term
    Leukoplakia oral
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA, Version 19.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      154
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      156
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      93
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      91
    term
    Pancreatitis
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA, Version 19.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      154
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      156
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      93
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      91
    term
    Pancreatitis acute
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA, Version 19.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      154
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      156
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      93
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      91
    term
    Chest pain
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    MedDRA, Version 19.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      154
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      156
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      93
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      91
    term
    Bile duct stone
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA, Version 19.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      154
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      156
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      93
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      91
    term
    Appendicitis
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA, Version 19.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      154
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      156
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      93
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      91
    term
    Bronchitis
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA, Version 19.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      154
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      156
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      93
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      91
    term
    Cellulitis
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA, Version 19.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      154
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      156
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      93
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      91
    term
    Groin infection
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA, Version 19.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      154
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      156
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      93
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      91
    term
    Hepatitis B
time Frame
Up to the data cutoff of July 13, 2018 (approximately 6 years).

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

Preserved source evidence · Not medical advice