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NCT03395080 · ADVERSE EVENTS

Adverse events

A Study of DKN-01 as a Monotherapy or in Combination With Paclitaxel in Patients With Recurrent Epithelial Endometrial or Epithelial Ovarian Cancer or Carcinosarcoma · Source last updated 2025-08-01

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
The Safety Analysis Set is all subjects who received greater than or equal to 1 administration of assigned study treatment (DKN-01 or paclitaxel). Subjects were followed for treatment emergent adverse events (AE), defined as any AE with an onset or worsening of a pre-existing condition on or after the first dose of the study drug through 30 days following the last dose of study drug, up to approximately 2 years.
Other-event reporting threshold
0%

Adverse events and serious adverse events reported are those that started or worsened after the first dose of study treatment and within 30 days after the last study treatment dose.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
DKN-01 Monotherapy in Recurrent EEC

300mg DKN-01 monotherapy in recurrent EEC. DKN-01 administered by IV infusion.

8 / 2929 / 2914 / 29
DKN-01+Paclitaxel in Recurrent EEC

300mg DKN-01+paclitaxel in recurrent EEC. DKN-01 administered by IV infusion.

13 / 2424 / 2416 / 24
DKN-01 Monotherapy in Recurrent EOC

300mg DKN-01 monotherapy in recurrent EOC. DKN-01 administered by IV infusion.

1 / 1413 / 1411 / 14
DKN-01+Paclitaxel in Recurrent EOC

300mg DKN-01+paclitaxel in recurrent EOC. DKN-01and paclitaxel administered by IV infusion.

6 / 1919 / 1912 / 19
300mg DKN-01 Monotherapy in Carcinosarcoma

300mg DKN-01 monotherapy in carcinosarcoma. DKN-01 administered by IV infusion.

1 / 11 / 10 / 1
600mg DKN-01 Monotherapy in Carcinosarcoma

600mg DKN-01 monotherapy in carcinosarcoma. DKN-01 administered by IV infusion.

2 / 88 / 84 / 8
300mg DKN-01+Paclitaxel in Carcinosarcoma

300mg DKN-01+paclitaxel in carcinosarcoma. DKN-01 and paclitaxel administered by IV infusion.

0 / 44 / 42 / 4
600mg DKN-01+Paclitaxel in Carcinosarcoma

600mg DKN-01+paclitaxel in carcinosarcoma. DKN-01 and paclitaxel administered by IV infusion.

6 / 1212 / 128 / 12

Group identifiers: EG000: DKN-01 Monotherapy in Recurrent EEC · EG001: DKN-01+Paclitaxel in Recurrent EEC · EG002: DKN-01 Monotherapy in Recurrent EOC · EG003: DKN-01+Paclitaxel in Recurrent EOC · EG004: 300mg DKN-01 Monotherapy in Carcinosarcoma · EG005: 600mg DKN-01 Monotherapy in Carcinosarcoma · EG006: 300mg DKN-01+Paclitaxel in Carcinosarcoma · EG007: 600mg DKN-01+Paclitaxel in Carcinosarcoma

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 (18.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      29
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      24
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      19
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      8
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      12
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      29
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      24
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      19
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      8
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      12
    term
    Sinus node dysfunction
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      29
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      24
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      19
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      8
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      12
    term
    Atrial fibrillation
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      29
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      24
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      19
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      8
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      12
    term
    Nausea
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      29
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      24
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      19
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      8
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      12
    term
    Abdominal pain
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      29
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      24
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      19
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      8
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      12
    term
    Gastrointestinal haemorrhage
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      29
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      24
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      19
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      8
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      12
    term
    Gastrointestinal perforation
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      29
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      24
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      19
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      8
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      12
    term
    Large intestinal obstruction
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      29
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      24
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      19
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      8
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      12
    term
    Vomiting
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      29
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      24
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      19
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      8
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      12
    term
    Ascites
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      29
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      24
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      19
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      8
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      12
    term
    Small intestinal obstruction
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      29
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      24
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      19
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      8
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      12
    term
    Colitis

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 (18.0)
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      29
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      24
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      19
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      8
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      4
      num At Risk
      12
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      29
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      24
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      5
      num At Risk
      19
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      8
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      2
      num At Risk
      12
    term
    Neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      29
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      24
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      19
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      8
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      12
    term
    Thrombocytopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      29
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      24
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      19
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      8
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      12
    term
    Abdominal lymphadenopathy
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      29
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      24
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      19
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      8
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      12
    term
    Iron deficiency anaemia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      29
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      24
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      19
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      8
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      2
      num At Risk
      12
    term
    Leukopenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      29
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      24
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      19
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      8
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      12
    term
    Lymphadenopathy
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      29
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      24
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      19
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      8
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      12
    term
    Lymphopenia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      29
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      24
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      19
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      8
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      12
    term
    Tachycardia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      29
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      24
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      19
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      8
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      12
    term
    Bradycardia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      29
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      24
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      19
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      8
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      12
    term
    Sinus arrest
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      29
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      24
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      19
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      8
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      12
    term
    Sinus node dysfunction
Complete source fields
description
Adverse events and serious adverse events reported are those that started or worsened after the first dose of study treatment and within 30 days after the last study treatment dose.
event Groups
  1. deaths Num Affected
    14
    deaths Num At Risk
    29
    description
    300mg DKN-01 monotherapy in recurrent EEC. DKN-01 administered by IV infusion.
    id
    EG000
    other Num Affected
    29
    other Num At Risk
    29
    serious Num Affected
    8
    serious Num At Risk
    29
    title
    DKN-01 Monotherapy in Recurrent EEC
  2. deaths Num Affected
    16
    deaths Num At Risk
    24
    description
    300mg DKN-01+paclitaxel in recurrent EEC. DKN-01 administered by IV infusion.
    id
    EG001
    other Num Affected
    24
    other Num At Risk
    24
    serious Num Affected
    13
    serious Num At Risk
    24
    title
    DKN-01+Paclitaxel in Recurrent EEC
  3. deaths Num Affected
    11
    deaths Num At Risk
    14
    description
    300mg DKN-01 monotherapy in recurrent EOC. DKN-01 administered by IV infusion.
    id
    EG002
    other Num Affected
    13
    other Num At Risk
    14
    serious Num Affected
    1
    serious Num At Risk
    14
    title
    DKN-01 Monotherapy in Recurrent EOC
  4. deaths Num Affected
    12
    deaths Num At Risk
    19
    description
    300mg DKN-01+paclitaxel in recurrent EOC. DKN-01and paclitaxel administered by IV infusion.
    id
    EG003
    other Num Affected
    19
    other Num At Risk
    19
    serious Num Affected
    6
    serious Num At Risk
    19
    title
    DKN-01+Paclitaxel in Recurrent EOC
  5. deaths Num Affected
    0
    deaths Num At Risk
    1
    description
    300mg DKN-01 monotherapy in carcinosarcoma. DKN-01 administered by IV infusion.
    id
    EG004
    other Num Affected
    1
    other Num At Risk
    1
    serious Num Affected
    1
    serious Num At Risk
    1
    title
    300mg DKN-01 Monotherapy in Carcinosarcoma
  6. deaths Num Affected
    4
    deaths Num At Risk
    8
    description
    600mg DKN-01 monotherapy in carcinosarcoma. DKN-01 administered by IV infusion.
    id
    EG005
    other Num Affected
    8
    other Num At Risk
    8
    serious Num Affected
    2
    serious Num At Risk
    8
    title
    600mg DKN-01 Monotherapy in Carcinosarcoma
  7. deaths Num Affected
    2
    deaths Num At Risk
    4
    description
    300mg DKN-01+paclitaxel in carcinosarcoma. DKN-01 and paclitaxel administered by IV infusion.
    id
    EG006
    other Num Affected
    4
    other Num At Risk
    4
    serious Num Affected
    0
    serious Num At Risk
    4
    title
    300mg DKN-01+Paclitaxel in Carcinosarcoma
  8. deaths Num Affected
    8
    deaths Num At Risk
    12
    description
    600mg DKN-01+paclitaxel in carcinosarcoma. DKN-01 and paclitaxel administered by IV infusion.
    id
    EG007
    other Num Affected
    12
    other Num At Risk
    12
    serious Num Affected
    6
    serious Num At Risk
    12
    title
    600mg DKN-01+Paclitaxel in Carcinosarcoma
frequency Threshold
0
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      29
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      24
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      19
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      8
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      4
      num At Risk
      12
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      29
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      24
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      5
      num At Risk
      19
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      8
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      2
      num At Risk
      12
    term
    Neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      29
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      24
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      19
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      8
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      12
    term
    Thrombocytopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      29
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      24
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      19
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      8
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      12
    term
    Abdominal lymphadenopathy
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      29
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      24
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      19
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      8
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      12
    term
    Iron deficiency anaemia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      29
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      24
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      19
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      8
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      2
      num At Risk
      12
    term
    Leukopenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      29
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      24
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      19
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      8
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      12
    term
    Lymphadenopathy
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      29
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      24
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      19
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      8
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      12
    term
    Lymphopenia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      29
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      24
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      19
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      8
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      12
    term
    Tachycardia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      29
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      24
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      19
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      8
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      12
    term
    Bradycardia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      29
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      24
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      19
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      8
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      12
    term
    Sinus arrest
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      29
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      24
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      19
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      8
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      12
    term
    Sinus node dysfunction
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      29
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      24
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      19
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      8
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      12
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      29
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      24
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      19
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      8
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      12
    term
    Sinus node dysfunction
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      29
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      24
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      19
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      8
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      12
    term
    Atrial fibrillation
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      29
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      24
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      19
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      8
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      12
    term
    Nausea
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      29
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      24
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      19
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      8
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      12
    term
    Abdominal pain
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      29
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      24
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      19
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      8
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      12
    term
    Gastrointestinal haemorrhage
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      29
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      24
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      19
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      8
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      12
    term
    Gastrointestinal perforation
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      29
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      24
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      19
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      8
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      12
    term
    Large intestinal obstruction
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      29
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      24
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      19
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      8
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      12
    term
    Vomiting
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      29
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      24
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      19
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      8
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      12
    term
    Ascites
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      29
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      24
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      19
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      8
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      12
    term
    Small intestinal obstruction
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      29
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      24
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      19
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      8
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      12
    term
    Colitis
time Frame
The Safety Analysis Set is all subjects who received greater than or equal to 1 administration of assigned study treatment (DKN-01 or paclitaxel). Subjects were followed for treatment emergent adverse events (AE), defined as any AE with an onset or worsening of a pre-existing condition on or after the first dose of the study drug through 30 days following the last dose of study drug, up to approximately 2 years.

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Preserved source evidence · Not medical advice