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NCT02278120 · ADVERSE EVENTS

Adverse events

Study of Efficacy and Safety in Premenopausal Women With Hormone Receptor Positive, HER2-negative Advanced Breast Cancer · Source last updated 2024-03-12

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
On-treatment: from 1st dose to 30 days post-treatment or start of crossover treatment, up to 90 months Crossover on-treatment: from 1st dose of crossover treatment to 30 days post-crossover treatment, up to approximately 33 months. Post-treatment survival follow-up: from day 31 post-treatment to end of study or start of crossover treatment, up to 90 months. Crossover post-treatment survival follow-up period from day 31 post-crossover treatment to end of study, up to approximately 33 months.
Other-event reporting threshold
5%

Safety analyses were performed in the safety set, including all participants who received at least one dose of study treatment. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Ribociclib + NSAI/Tamoxifen + Goserelin (On-treatment)

AEs collected during on-treatment period (up to 30 days post-treatment)

81 / 335326 / 3355 / 335
Placebo + NSAI/Tamoxifen+ Goserelin (On-treatment)

AEs collected during on-treatment period (up to 30 days post-treatment or start of crossover treatment)

49 / 337312 / 3376 / 337
Placebo Crossover to Ribociclib (On-Treatment)

AEs collected during crossover on-treatment period with ribociclib for participants randomized to placebo arm who crossed-over to ribociclib (up to 30 days post- crossover treatment)

1 / 1714 / 170 / 17
Ribociclib + NSAI/Tamoxifen + Goserelin (Post-treatment Survival Follow-up)

Deaths collected in the post- treatment survival follow-up period (starting from day 31 post- treatment to end of study). No AEs were collected during this period

0 / 00 / 0168 / 251
Placebo + NSAI/Tamoxifen+ Goserelin (Post-treatment Survival Follow-up)

Deaths collected in the post- treatment survival follow-up period (starting from day 31 post- treatment to end of study or start of crossover treatment). No AEs were collected during this period

0 / 00 / 0202 / 293
Placebo Crossover to Ribociclib (Post-treatment Survival Follow-up)

Deaths collected in the crossover post- treatment survival follow-up period (starting from day 31 post-crossover treatment to end of study). No AEs were collected during this period

0 / 00 / 01 / 17

Group identifiers: EG000: Ribociclib + NSAI/Tamoxifen + Goserelin (On-treatment) · EG001: Placebo + NSAI/Tamoxifen+ Goserelin (On-treatment) · EG002: Placebo Crossover to Ribociclib (On-Treatment) · EG003: Ribociclib + NSAI/Tamoxifen + Goserelin (Post-treatment Survival Follow-up) · EG004: Placebo + NSAI/Tamoxifen+ Goserelin (Post-treatment Survival Follow-up) · EG005: Placebo Crossover to Ribociclib (Post-treatment Survival Follow-up)

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
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (26.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      335
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      337
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      17
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num At Risk
      0
    6. group Id
      EG005
      num At Risk
      0
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (26.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      335
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      337
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      17
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num At Risk
      0
    6. group Id
      EG005
      num At Risk
      0
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (26.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      335
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      337
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      17
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num At Risk
      0
    6. group Id
      EG005
      num At Risk
      0
    term
    Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (26.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      335
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      337
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      17
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num At Risk
      0
    6. group Id
      EG005
      num At Risk
      0
    term
    Acute myocardial infarction
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (26.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      335
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      337
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      17
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num At Risk
      0
    6. group Id
      EG005
      num At Risk
      0
    term
    Arrhythmia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (26.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      335
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      337
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      17
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num At Risk
      0
    6. group Id
      EG005
      num At Risk
      0
    term
    Pericardial effusion
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (26.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      335
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      337
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      17
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num At Risk
      0
    6. group Id
      EG005
      num At Risk
      0
    term
    Sinus tachycardia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (26.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      335
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      337
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      17
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num At Risk
      0
    6. group Id
      EG005
      num At Risk
      0
    term
    Abdominal pain
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (26.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      335
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      337
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      17
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num At Risk
      0
    6. group Id
      EG005
      num At Risk
      0
    term
    Ascites
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (26.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      335
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      337
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      17
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num At Risk
      0
    6. group Id
      EG005
      num At Risk
      0
    term
    Diarrhoea
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (26.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      335
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      337
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      17
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num At Risk
      0
    6. group Id
      EG005
      num At Risk
      0
    term
    Dysphagia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (26.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      335
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      337
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      17
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num At Risk
      0
    6. group Id
      EG005
      num At Risk
      0
    term
    Enterocolitis

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
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (26.0)
    stats
    1. group Id
      EG000
      num Affected
      73
      num At Risk
      335
    2. group Id
      EG001
      num Affected
      37
      num At Risk
      337
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      17
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num At Risk
      0
    6. group Id
      EG005
      num At Risk
      0
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (26.0)
    stats
    1. group Id
      EG000
      num Affected
      66
      num At Risk
      335
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      337
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      17
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num At Risk
      0
    6. group Id
      EG005
      num At Risk
      0
    term
    Leukopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (26.0)
    stats
    1. group Id
      EG000
      num Affected
      29
      num At Risk
      335
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      337
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      17
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num At Risk
      0
    6. group Id
      EG005
      num At Risk
      0
    term
    Lymphopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (26.0)
    stats
    1. group Id
      EG000
      num Affected
      194
      num At Risk
      335
    2. group Id
      EG001
      num Affected
      22
      num At Risk
      337
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      17
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num At Risk
      0
    6. group Id
      EG005
      num At Risk
      0
    term
    Neutropenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (26.0)
    stats
    1. group Id
      EG000
      num Affected
      24
      num At Risk
      335
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      337
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      17
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num At Risk
      0
    6. group Id
      EG005
      num At Risk
      0
    term
    Thrombocytopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA (26.0)
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      335
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      337
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      17
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num At Risk
      0
    6. group Id
      EG005
      num At Risk
      0
    term
    Lacrimation increased
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (26.0)
    stats
    1. group Id
      EG000
      num Affected
      39
      num At Risk
      335
    2. group Id
      EG001
      num Affected
      27
      num At Risk
      337
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      17
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num At Risk
      0
    6. group Id
      EG005
      num At Risk
      0
    term
    Abdominal pain
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (26.0)
    stats
    1. group Id
      EG000
      num Affected
      27
      num At Risk
      335
    2. group Id
      EG001
      num Affected
      24
      num At Risk
      337
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      17
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num At Risk
      0
    6. group Id
      EG005
      num At Risk
      0
    term
    Abdominal pain upper
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (26.0)
    stats
    1. group Id
      EG000
      num Affected
      62
      num At Risk
      335
    2. group Id
      EG001
      num Affected
      48
      num At Risk
      337
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      17
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num At Risk
      0
    6. group Id
      EG005
      num At Risk
      0
    term
    Constipation
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (26.0)
    stats
    1. group Id
      EG000
      num Affected
      82
      num At Risk
      335
    2. group Id
      EG001
      num Affected
      67
      num At Risk
      337
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      17
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num At Risk
      0
    6. group Id
      EG005
      num At Risk
      0
    term
    Diarrhoea
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (26.0)
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      335
    2. group Id
      EG001
      num Affected
      18
      num At Risk
      337
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      17
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num At Risk
      0
    6. group Id
      EG005
      num At Risk
      0
    term
    Dry mouth
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (26.0)
    stats
    1. group Id
      EG000
      num Affected
      20
      num At Risk
      335
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      337
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      17
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num At Risk
      0
    6. group Id
      EG005
      num At Risk
      0
    term
    Dyspepsia
Complete source fields
description
Safety analyses were performed in the safety set, including all participants who received at least one dose of study treatment. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
event Groups
  1. deaths Num Affected
    5
    deaths Num At Risk
    335
    description
    AEs collected during on-treatment period (up to 30 days post-treatment)
    id
    EG000
    other Num Affected
    326
    other Num At Risk
    335
    serious Num Affected
    81
    serious Num At Risk
    335
    title
    Ribociclib + NSAI/Tamoxifen + Goserelin (On-treatment)
  2. deaths Num Affected
    6
    deaths Num At Risk
    337
    description
    AEs collected during on-treatment period (up to 30 days post-treatment or start of crossover treatment)
    id
    EG001
    other Num Affected
    312
    other Num At Risk
    337
    serious Num Affected
    49
    serious Num At Risk
    337
    title
    Placebo + NSAI/Tamoxifen+ Goserelin (On-treatment)
  3. deaths Num Affected
    0
    deaths Num At Risk
    17
    description
    AEs collected during crossover on-treatment period with ribociclib for participants randomized to placebo arm who crossed-over to ribociclib (up to 30 days post- crossover treatment)
    id
    EG002
    other Num Affected
    14
    other Num At Risk
    17
    serious Num Affected
    1
    serious Num At Risk
    17
    title
    Placebo Crossover to Ribociclib (On-Treatment)
  4. deaths Num Affected
    168
    deaths Num At Risk
    251
    description
    Deaths collected in the post- treatment survival follow-up period (starting from day 31 post- treatment to end of study). No AEs were collected during this period
    id
    EG003
    other Num Affected
    0
    other Num At Risk
    0
    serious Num Affected
    0
    serious Num At Risk
    0
    title
    Ribociclib + NSAI/Tamoxifen + Goserelin (Post-treatment Survival Follow-up)
  5. deaths Num Affected
    202
    deaths Num At Risk
    293
    description
    Deaths collected in the post- treatment survival follow-up period (starting from day 31 post- treatment to end of study or start of crossover treatment). No AEs were collected during this period
    id
    EG004
    other Num Affected
    0
    other Num At Risk
    0
    serious Num Affected
    0
    serious Num At Risk
    0
    title
    Placebo + NSAI/Tamoxifen+ Goserelin (Post-treatment Survival Follow-up)
  6. deaths Num Affected
    1
    deaths Num At Risk
    17
    description
    Deaths collected in the crossover post- treatment survival follow-up period (starting from day 31 post-crossover treatment to end of study). No AEs were collected during this period
    id
    EG005
    other Num Affected
    0
    other Num At Risk
    0
    serious Num Affected
    0
    serious Num At Risk
    0
    title
    Placebo Crossover to Ribociclib (Post-treatment Survival Follow-up)
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (26.0)
    stats
    1. group Id
      EG000
      num Affected
      73
      num At Risk
      335
    2. group Id
      EG001
      num Affected
      37
      num At Risk
      337
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      17
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num At Risk
      0
    6. group Id
      EG005
      num At Risk
      0
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (26.0)
    stats
    1. group Id
      EG000
      num Affected
      66
      num At Risk
      335
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      337
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      17
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num At Risk
      0
    6. group Id
      EG005
      num At Risk
      0
    term
    Leukopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (26.0)
    stats
    1. group Id
      EG000
      num Affected
      29
      num At Risk
      335
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      337
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      17
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num At Risk
      0
    6. group Id
      EG005
      num At Risk
      0
    term
    Lymphopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (26.0)
    stats
    1. group Id
      EG000
      num Affected
      194
      num At Risk
      335
    2. group Id
      EG001
      num Affected
      22
      num At Risk
      337
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      17
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num At Risk
      0
    6. group Id
      EG005
      num At Risk
      0
    term
    Neutropenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (26.0)
    stats
    1. group Id
      EG000
      num Affected
      24
      num At Risk
      335
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      337
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      17
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num At Risk
      0
    6. group Id
      EG005
      num At Risk
      0
    term
    Thrombocytopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA (26.0)
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      335
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      337
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      17
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num At Risk
      0
    6. group Id
      EG005
      num At Risk
      0
    term
    Lacrimation increased
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (26.0)
    stats
    1. group Id
      EG000
      num Affected
      39
      num At Risk
      335
    2. group Id
      EG001
      num Affected
      27
      num At Risk
      337
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      17
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num At Risk
      0
    6. group Id
      EG005
      num At Risk
      0
    term
    Abdominal pain
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (26.0)
    stats
    1. group Id
      EG000
      num Affected
      27
      num At Risk
      335
    2. group Id
      EG001
      num Affected
      24
      num At Risk
      337
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      17
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num At Risk
      0
    6. group Id
      EG005
      num At Risk
      0
    term
    Abdominal pain upper
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (26.0)
    stats
    1. group Id
      EG000
      num Affected
      62
      num At Risk
      335
    2. group Id
      EG001
      num Affected
      48
      num At Risk
      337
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      17
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num At Risk
      0
    6. group Id
      EG005
      num At Risk
      0
    term
    Constipation
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (26.0)
    stats
    1. group Id
      EG000
      num Affected
      82
      num At Risk
      335
    2. group Id
      EG001
      num Affected
      67
      num At Risk
      337
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      17
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num At Risk
      0
    6. group Id
      EG005
      num At Risk
      0
    term
    Diarrhoea
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (26.0)
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      335
    2. group Id
      EG001
      num Affected
      18
      num At Risk
      337
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      17
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num At Risk
      0
    6. group Id
      EG005
      num At Risk
      0
    term
    Dry mouth
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (26.0)
    stats
    1. group Id
      EG000
      num Affected
      20
      num At Risk
      335
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      337
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      17
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num At Risk
      0
    6. group Id
      EG005
      num At Risk
      0
    term
    Dyspepsia
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (26.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      335
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      337
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      17
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num At Risk
      0
    6. group Id
      EG005
      num At Risk
      0
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (26.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      335
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      337
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      17
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num At Risk
      0
    6. group Id
      EG005
      num At Risk
      0
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (26.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      335
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      337
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      17
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num At Risk
      0
    6. group Id
      EG005
      num At Risk
      0
    term
    Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (26.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      335
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      337
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      17
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num At Risk
      0
    6. group Id
      EG005
      num At Risk
      0
    term
    Acute myocardial infarction
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (26.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      335
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      337
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      17
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num At Risk
      0
    6. group Id
      EG005
      num At Risk
      0
    term
    Arrhythmia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (26.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      335
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      337
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      17
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num At Risk
      0
    6. group Id
      EG005
      num At Risk
      0
    term
    Pericardial effusion
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (26.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      335
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      337
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      17
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num At Risk
      0
    6. group Id
      EG005
      num At Risk
      0
    term
    Sinus tachycardia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (26.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      335
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      337
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      17
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num At Risk
      0
    6. group Id
      EG005
      num At Risk
      0
    term
    Abdominal pain
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (26.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      335
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      337
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      17
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num At Risk
      0
    6. group Id
      EG005
      num At Risk
      0
    term
    Ascites
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (26.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      335
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      337
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      17
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num At Risk
      0
    6. group Id
      EG005
      num At Risk
      0
    term
    Diarrhoea
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (26.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      335
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      337
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      17
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num At Risk
      0
    6. group Id
      EG005
      num At Risk
      0
    term
    Dysphagia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (26.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      335
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      337
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      17
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num At Risk
      0
    6. group Id
      EG005
      num At Risk
      0
    term
    Enterocolitis
time Frame
On-treatment: from 1st dose to 30 days post-treatment or start of crossover treatment, up to 90 months Crossover on-treatment: from 1st dose of crossover treatment to 30 days post-crossover treatment, up to approximately 33 months. Post-treatment survival follow-up: from day 31 post-treatment to end of study or start of crossover treatment, up to 90 months. Crossover post-treatment survival follow-up period from day 31 post-crossover treatment to end of study, up to approximately 33 months.

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Preserved source evidence · Not medical advice