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NCT03180294 · ADVERSE EVENTS

Adverse events

Bupropion Hydrochloride in Improving Sexual Desire in Women With Breast or Gynecologic Cancer · Source last updated 2026-07-10

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
1,2,5,7, and 9 weeks from start of study treatment (within 21 days of randomization).]
Other-event reporting threshold
5%

All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants with adverse event data who started protocol treatment.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Bupropion 150 mg

One Bupropion 150 mg XL capsule PO in a.m. daily for one week; one Bupropion 150 mg XL capsule and one placebo capsule PO in a.m. daily for 8 weeks; one placebo capsule daily PO in a.m. for one 1 week (titration off).

1 / 7753 / 770 / 79
Bupropion 300 mg

One Bupropion 150 mg XL capsule PO in a.m. daily for one week; two Bupropion 150 mg XL capsules PO in a.m. daily for 8 weeks (300 mg target dose); one Bupropion 150 mg XL capsule PO in a.m. daily for 1 week (titration off)

0 / 7355 / 730 / 74
Placebo

One placebo capsule PO in a.m. daily for 1 week; two placebo capsules PO in a.m. daily for 8 weeks; one placebo capsule PO in a.m. daily for 1 week (titration off)

0 / 7657 / 760 / 77

Group identifiers: EG000: Bupropion 150 mg · EG001: Bupropion 300 mg · EG002: 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
    Psychiatric disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      77
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      73
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      76
    term
    Insomnia

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
    Ear and labyrinth disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      77
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      73
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      76
    term
    Tinnitus
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      23
      num At Risk
      77
    2. group Id
      EG001
      num Affected
      24
      num At Risk
      73
    3. group Id
      EG002
      num Affected
      20
      num At Risk
      76
    term
    Constipation
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      77
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      73
    3. group Id
      EG002
      num Affected
      8
      num At Risk
      76
    term
    Diarrhea
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      21
      num At Risk
      77
    2. group Id
      EG001
      num Affected
      30
      num At Risk
      73
    3. group Id
      EG002
      num Affected
      25
      num At Risk
      76
    term
    Dry mouth
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      77
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      73
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      76
    term
    Gastroesophageal reflux disease
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      77
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      73
    3. group Id
      EG002
      num Affected
      22
      num At Risk
      76
    term
    Nausea
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      77
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      73
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      76
    term
    Fatigue
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      77
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      73
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      76
    term
    Pain
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      77
    2. group Id
      EG001
      num Affected
      15
      num At Risk
      73
    3. group Id
      EG002
      num Affected
      20
      num At Risk
      76
    term
    Anorexia
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      77
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      73
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      76
    term
    Arthralgia
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      77
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      73
    3. group Id
      EG002
      num Affected
      14
      num At Risk
      76
    term
    Dizziness
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      23
      num At Risk
      77
    2. group Id
      EG001
      num Affected
      36
      num At Risk
      73
    3. group Id
      EG002
      num Affected
      30
      num At Risk
      76
    term
    Headache
Complete source fields
description
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants with adverse event data who started protocol treatment.
event Groups
  1. deaths Num Affected
    0
    deaths Num At Risk
    79
    description
    One Bupropion 150 mg XL capsule PO in a.m. daily for one week; one Bupropion 150 mg XL capsule and one placebo capsule PO in a.m. daily for 8 weeks; one placebo capsule daily PO in a.m. for one 1 week (titration off).
    id
    EG000
    other Num Affected
    53
    other Num At Risk
    77
    serious Num Affected
    1
    serious Num At Risk
    77
    title
    Bupropion 150 mg
  2. deaths Num Affected
    0
    deaths Num At Risk
    74
    description
    One Bupropion 150 mg XL capsule PO in a.m. daily for one week; two Bupropion 150 mg XL capsules PO in a.m. daily for 8 weeks (300 mg target dose); one Bupropion 150 mg XL capsule PO in a.m. daily for 1 week (titration off)
    id
    EG001
    other Num Affected
    55
    other Num At Risk
    73
    serious Num Affected
    0
    serious Num At Risk
    73
    title
    Bupropion 300 mg
  3. deaths Num Affected
    0
    deaths Num At Risk
    77
    description
    One placebo capsule PO in a.m. daily for 1 week; two placebo capsules PO in a.m. daily for 8 weeks; one placebo capsule PO in a.m. daily for 1 week (titration off)
    id
    EG002
    other Num Affected
    57
    other Num At Risk
    76
    serious Num Affected
    0
    serious Num At Risk
    76
    title
    Placebo
frequency Threshold
5
other Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      77
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      73
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      76
    term
    Tinnitus
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      23
      num At Risk
      77
    2. group Id
      EG001
      num Affected
      24
      num At Risk
      73
    3. group Id
      EG002
      num Affected
      20
      num At Risk
      76
    term
    Constipation
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      77
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      73
    3. group Id
      EG002
      num Affected
      8
      num At Risk
      76
    term
    Diarrhea
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      21
      num At Risk
      77
    2. group Id
      EG001
      num Affected
      30
      num At Risk
      73
    3. group Id
      EG002
      num Affected
      25
      num At Risk
      76
    term
    Dry mouth
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      77
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      73
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      76
    term
    Gastroesophageal reflux disease
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      77
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      73
    3. group Id
      EG002
      num Affected
      22
      num At Risk
      76
    term
    Nausea
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      77
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      73
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      76
    term
    Fatigue
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      77
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      73
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      76
    term
    Pain
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      77
    2. group Id
      EG001
      num Affected
      15
      num At Risk
      73
    3. group Id
      EG002
      num Affected
      20
      num At Risk
      76
    term
    Anorexia
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      77
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      73
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      76
    term
    Arthralgia
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      77
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      73
    3. group Id
      EG002
      num Affected
      14
      num At Risk
      76
    term
    Dizziness
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      23
      num At Risk
      77
    2. group Id
      EG001
      num Affected
      36
      num At Risk
      73
    3. group Id
      EG002
      num Affected
      30
      num At Risk
      76
    term
    Headache
serious Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      77
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      73
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      76
    term
    Insomnia
time Frame
1,2,5,7, and 9 weeks from start of study treatment (within 21 days of randomization).]

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