GLOW: Safety and Efficacy of AZD4547 in Combination With Fulvestrant vs. Fulvestrant Alone in ER+ Breast Cancer Patients
Sponsor
AstraZeneca (Industry)
Overall Status
Completed
CT.gov ID
NCT01202591
Collaborator
(none)
127
21
3
46
6
0.1
Study Details
Study Description
Brief Summary
The purpose of this study is to assess the safety and effectiveness of AZD4547 in combination with fulvestrant vs. fulvestrant alone in ER+ breast cancer patients with FGFR1 polysomy (FISH4/5) or gene amplification (FISH 6)
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1/Phase 2 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
127 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Randomised Double-blind Phase IIa Study (With Combination Safety Run-in) to Assess the Safety and Efficacy of AZD4547 in Combination With Fulvestrant vs. Fulvestrant Alone in ER+ Breast Cancer Patients With FGFR1 Polysomy or Gene Amplification Who Have Progressed Following Treatment With Prior Endocrine Therapy (Adjuvant or First-line Metastatic) (GLOW)
Study Start Date
:
Dec 1, 2010
Actual Primary Completion Date
:
Sep 1, 2014
Actual Study Completion Date
:
Oct 1, 2014
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: AZD4547 + exemestane Safety run-in: AZD4547 plus exemestane |
Drug: AZD4547
Tablet oral twice daily
Drug: Exemestane
Tablet oral once daily
|
| Experimental: AZD4547 + fulvestrant A Randomised phase IIa: AZD4547 plus fulvestrant |
Drug: AZD4547
Tablet oral twice daily
Drug: Fulvestrant
A monthly intramuscular injection of a depot formulation with a loading dose 14 days after initial administration
|
| Placebo Comparator: Placebo + fulvestrant Randomised phase IIa: Matching placebo plus fulvestrant |
Drug: Placebo
Tablet oral twice daily
Drug: Fulvestrant
A monthly intramuscular injection of a depot formulation with a loading dose 14 days after initial administration
|
Outcome Measures
Primary Outcome Measures
- Safety and Tolerability in Terms of Number of Patients With Adverse Events (Serious and Non-serious) [3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 99 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Post-menopausal women (either through bilateral oophorectomy or amenorrhoeic for 24 months)
-
Histological confirmation of Breast Cancer with documented ER+ receptor status
-
Safety run-in: Relapsing during/within 12 months of completion of a single regimen of adjuvant endocrine therapy with non-steroidal AI and/ tamoxifen or progression following 1st line endocrine therapy with non-steroidal AL
-
Rand phase IIa: Received at least 1 prior endocrine therapy in the metastatic setting or have relapsed during/ within 6 months of completion of adjuvant endocrine therapy (either non-steroidal AI or tamoxifen or a combination of both). Chemotherapy administered in the adjuvant setting is permitted.
-
Rand phase IIa: Mandatory provision of tumour sample to confirm FGFR1 polysomy or gene amplification. At least one measurable lesion that can be accurately assessed by CT/MRI/x-ray at baseline and follow up visits
Exclusion Criteria:
-
Prior exposure to exemestane (safety run-in) / fulvestrant (randomized phase IIa), or any agent known to inhibit FGFRs.
-
More than 1 prior regimen of chemotherapy for breast cancer
-
ECG recordings that demonstrate significant abnormalities in cardiac rate, rhythm or conduction
-
History of hypersensitivity to active or inactive excipients of AZD4547 or exemestane (safety run-in ) or fulvestrant (Randomized phase), including castor oil, or drugs with a similar chemical structure or class to AZD4547 or exemestane or fulvestrant.
-
Randomized phase IIa: bleeding/blood clotting conditions that would prevent the administration of the fulvestrant injection into the buttocks
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Research Site | Leuven | Belgium | ||
| 2 | Research Site | Namur | Belgium | ||
| 3 | Research Site | Brno | Czech Republic | ||
| 4 | Research Site | Praha 4 | Czech Republic | ||
| 5 | Research Site | Villejuif Cedex | France | ||
| 6 | Research Site | Erlangen | Germany | ||
| 7 | Research Site | München | Germany | ||
| 8 | Research Site | Rostock | Germany | ||
| 9 | Research Site | Budapest | Hungary | ||
| 10 | Research Site | Kaposvár | Hungary | ||
| 11 | Research Site | Nyíregyháza | Hungary | ||
| 12 | Research Site | Szeged | Hungary | ||
| 13 | Research Site | Genova | Italy | ||
| 14 | Research Site | Lido di Camaiore | Italy | ||
| 15 | Research Site | Roma | Italy | ||
| 16 | Research Site | Cluj Napoca | Romania | ||
| 17 | Research Site | Dundee | United Kingdom | ||
| 18 | Research Site | London | United Kingdom | ||
| 19 | Research Site | Manchester | United Kingdom | ||
| 20 | Research Site | Oxford | United Kingdom | ||
| 21 | Research Site | Sutton | United Kingdom |
Sponsors and Collaborators
- AstraZeneca
Investigators
- Study Director: Donal Landers, AstraZeneca
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01202591
Other Study ID Numbers:
- D2610C00003
- 2010-021220-10
First Posted:
Sep 16, 2010
Last Update Posted:
Feb 11, 2016
Last Verified:
Jan 1, 2016
Keywords provided by AstraZeneca
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | First patient was enrolled on 8 Dec 2010 and Last patient last visit was on 21 Oct 2014. Recruitment was slow, leading to concerns about the feasibility of completing enrolment. Moreover, the limited evidence of clinical activity of AZD4547 monotherapy in FGFR gastric cancer and NSCLC has resulted in a business decision to terminate enrolment. |
|---|---|
| Pre-assignment Detail | Part A: 38 patients enrolled, 31 patients received AZD4547+exemestane; 7 patients did not receive (5 patients were not eligible, 1 patient due to patient decision, 1 patient due to "Other") Part B: 89 patients enrolled; 80 were not eligible, 9 patients received the treatment |
| Arm/Group Title | AZD4547 80mg bd Cont + Ex 25mg | AZD4547 40mg Cont + Ex 25mg | AZD4547 80mg bd 1w/1w + Ex 25mg | AZD4547 80mg bd 2w/1w + Ex | Part B: AZD4547 + Fulvestrant | Part B: Placebo + Fulvestrant |
|---|---|---|---|---|---|---|
| Arm/Group Description | 80 mg AZD4547 BD continuous + 25 mg exemestane | 40 mg AZD4547 BD continuous + 25 mg exemestane | 80 mg AZD4547 bd one week on/one week off + 25 mg exemestane | 80 mg AZD4547 BD two week on/one week off + 25 mg exemestane | 80 mg AZD4547 BD + 500 mg Fulvestrant | 80mg Placebo BD + 500 mg Fulvestrant |
| Period Title: Overall Study | ||||||
| STARTED | 5 | 5 | 12 | 9 | 5 | 4 |
| COMPLETED | 0 | 0 | 1 | 2 | 0 | 0 |
| NOT COMPLETED | 5 | 5 | 11 | 7 | 5 | 4 |
Baseline Characteristics
| Arm/Group Title | AZD4547 80mg bd Cont + Ex 25mg | AZD4547 40mg bd Cont + Ex 25mg | AZD4547 80mg bd 1w/1w + Ex 25mg | AZD4547 80mg bd 2w/1w + Ex 25mg | Part B: AZD4547 + Fulvestrant | Part B: Placebo + Fulvestrant | Total |
|---|---|---|---|---|---|---|---|
| Arm/Group Description | 80 mg AZD4547 bd continuous + 25 mg exemestane | 40 mg AZD4547 BD continuous + 25 mg exemestane | 80 mg AZD4547 BD one week on/one week off + 25 mg exemestane | 80 mg AZD4547 bd two week on/one week off + 25 mg exemestane | 80 mg AZD4547 BD + 500 mg Fulvestrant | 80 mg Placebo BD + 500 mg Fulvestrant | Total of all reporting groups |
| Overall Participants | 5 | 5 | 12 | 9 | 5 | 4 | 40 |
| Age (Years) [Mean (Standard Deviation) ] | |||||||
| Mean (Standard Deviation) [Years] |
58.4
(16.70)
|
61.2
(9.36)
|
66.5
(8.46)
|
67.3
(9.66)
|
61.0
(6.82)
|
67.3
(9.46)
|
64.6
(10.58)
|
| Age, Customized (Number) [Number] | |||||||
| < 35 |
1
20%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
1
2.5%
|
| 35 >= - < 50 |
0
0%
|
1
20%
|
1
8.3%
|
0
0%
|
0
0%
|
0
0%
|
2
5%
|
| 50 >= - <65 |
2
40%
|
2
40%
|
3
25%
|
3
33.3%
|
4
80%
|
1
25%
|
15
37.5%
|
| >= 65 |
2
40%
|
2
40%
|
8
66.7%
|
6
66.7%
|
1
20%
|
3
75%
|
22
55%
|
| Sex/Gender, Customized (Number) [Number] | |||||||
| Female |
5
100%
|
5
100%
|
12
100%
|
9
100%
|
5
100%
|
4
100%
|
40
100%
|
| Race/Ethnicity, Customized (Number) [Number] | |||||||
| Asian (Other Than Chinese And Japanese) |
1
20%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
1
2.5%
|
| Not Applicable |
2
40%
|
0
0%
|
8
66.7%
|
4
44.4%
|
2
40%
|
0
0%
|
16
40%
|
| Other |
2
40%
|
5
100%
|
4
33.3%
|
5
55.6%
|
3
60%
|
4
100%
|
23
57.5%
|
| Race/Ethnicity, Customized (Number) [Number] | |||||||
| White |
4
80%
|
5
100%
|
11
91.7%
|
9
100%
|
5
100%
|
4
100%
|
38
95%
|
| Other |
1
20%
|
0
0%
|
1
8.3%
|
0
0%
|
0
0%
|
0
0%
|
2
5%
|
Outcome Measures
| Title | Safety and Tolerability in Terms of Number of Patients With Adverse Events (Serious and Non-serious) |
|---|---|
| Description | |
| Time Frame | 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up). |
Outcome Measure Data
| Analysis Population Description |
|---|
| All patients who receive at least one dose of study treatment (AZD4547 or exemestane) |
| Arm/Group Title | AZD4547 80mg bd Cont + Ex 25mg | AZD4547 40mg Cont + Ex 25mg | AZD4547 80mg bd 1w/1w + Ex 25mg | AZD4547 80mg bd 2w/1w + Ex 25mg | Part B: AZD4547 + Fulvestrant | Part B: Placebo + Fulvestrant |
|---|---|---|---|---|---|---|
| Arm/Group Description | 80 mg AZD4547 BD continuous + 25 mg exemestane | 40 mg AZD4547 BD continuous + 25 mg exemestane | 80 mg AZD4547 bd one week on/one week off + 25 mg exemestane | 80 mg AZD4547 BD two week on/one week off + 25 mg exemestane | 80 mg AZD4547 BD + 500 mg Fulvestrant | 80mg Placebo BD + 500 mg Fulvestrant |
| Measure Participants | 5 | 5 | 12 | 9 | 5 | 4 |
| Number [Participants] |
5
100%
|
5
100%
|
12
100%
|
9
100%
|
5
100%
|
2
50%
|
Adverse Events
| Time Frame | 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up). | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | ||||||||||||
| Arm/Group Title | AZD4547 80mg bd Cont + Ex 25mg | AZD4547 40mg bd Cont + Ex 25mg | AZD4547 80mg bd 1w/1w + Ex 25mg | AZD4547 80mg bd 2w/1w + Ex 25mg | Part B: AZD4547 + Fulvestrant | Part B: Placebo + Fulvestrant | ||||||
| Arm/Group Description | 80 mg AZD4547 bd continuous + 25 mg exemestane | 40 mg AZD4547 BD continuous + 25 mg exemestane | 80 mg AZD4547 BD one week on/one week off + 25 mg exemestane | 80 mg AZD4547 bd two week on/one week off + 25 mg exemestane | 80 mg AZD4547 BD + 500 mg Fulvestrant | 80 mg Placebo BD + 500 mg Fulvestrant | ||||||
All Cause Mortality |
||||||||||||
| AZD4547 80mg bd Cont + Ex 25mg | AZD4547 40mg bd Cont + Ex 25mg | AZD4547 80mg bd 1w/1w + Ex 25mg | AZD4547 80mg bd 2w/1w + Ex 25mg | Part B: AZD4547 + Fulvestrant | Part B: Placebo + Fulvestrant | |||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | ||||||
Serious Adverse Events |
||||||||||||
| AZD4547 80mg bd Cont + Ex 25mg | AZD4547 40mg bd Cont + Ex 25mg | AZD4547 80mg bd 1w/1w + Ex 25mg | AZD4547 80mg bd 2w/1w + Ex 25mg | Part B: AZD4547 + Fulvestrant | Part B: Placebo + Fulvestrant | |||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 2/5 (40%) | 2/5 (40%) | 5/12 (41.7%) | 1/9 (11.1%) | 1/5 (20%) | 1/4 (25%) | ||||||
| Blood and lymphatic system disorders | ||||||||||||
| ANAEMIA | 0/5 (0%) | 0 | 1/5 (20%) | 1 | 1/12 (8.3%) | 1 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/4 (0%) | 0 |
| Gastrointestinal disorders | ||||||||||||
| DIARRHOEA | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/12 (0%) | 0 | 1/9 (11.1%) | 1 | 0/5 (0%) | 0 | 0/4 (0%) | 0 |
| OESOPHAGEAL ACHALASIA | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 1/12 (8.3%) | 1 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/4 (0%) | 0 |
| STOMATITIS | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 1/12 (8.3%) | 1 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/4 (0%) | 0 |
| General disorders | ||||||||||||
| DEVICE DEPOSIT ISSUE | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 1/12 (8.3%) | 1 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/4 (0%) | 0 |
| INFLAMMATION | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/12 (0%) | 0 | 0/9 (0%) | 0 | 1/5 (20%) | 1 | 0/4 (0%) | 0 |
| GAIT DISTURBANCE | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/12 (0%) | 0 | 0/9 (0%) | 0 | 1/5 (20%) | 1 | 0/4 (0%) | 0 |
| Infections and infestations | ||||||||||||
| LOWER RESPIRATORY TRACT INFECTION VIRAL | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 1/12 (8.3%) | 1 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/4 (0%) | 0 |
| NEUTROPENIC SEPSIS | 1/5 (20%) | 1 | 0/5 (0%) | 0 | 0/12 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/4 (0%) | 0 |
| PLEURAL INFECTION | 1/5 (20%) | 1 | 0/5 (0%) | 0 | 0/12 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/4 (0%) | 0 |
| PYELONEPHRITIS | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 1/12 (8.3%) | 1 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/4 (0%) | 0 |
| Investigations | ||||||||||||
| TROPONIN INCREASED | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 1/12 (8.3%) | 1 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/4 (0%) | 0 |
| Musculoskeletal and connective tissue disorders | ||||||||||||
| ACUTE CRISIS OF PSORIASIC OLIGOARTHRITIS | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/12 (0%) | 0 | 0/9 (0%) | 0 | 1/5 (20%) | 1 | 0/4 (0%) | 0 |
| Nervous system disorders | ||||||||||||
| DIZZINESS | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 1/12 (8.3%) | 1 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 1/4 (25%) | 1 |
| VIITH NERVE PARALYSIS | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 1/12 (8.3%) | 1 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/4 (0%) | 0 |
| Renal and urinary disorders | ||||||||||||
| RENAL FAILURE | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 1/12 (8.3%) | 1 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/4 (0%) | 0 |
| Respiratory, thoracic and mediastinal disorders | ||||||||||||
| ASTHMA | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 1/12 (8.3%) | 1 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/4 (0%) | 0 |
| DYSPNOEA | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 1/12 (8.3%) | 2 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/4 (0%) | 0 |
| PLEURAL EFFUSION | 0/5 (0%) | 0 | 1/5 (20%) | 1 | 0/12 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/4 (0%) | 0 |
| Vascular disorders | ||||||||||||
| JUGULAR VEIN THROMBOSIS | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 1/12 (8.3%) | 1 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/4 (0%) | 0 |
Other (Not Including Serious) Adverse Events |
||||||||||||
| AZD4547 80mg bd Cont + Ex 25mg | AZD4547 40mg bd Cont + Ex 25mg | AZD4547 80mg bd 1w/1w + Ex 25mg | AZD4547 80mg bd 2w/1w + Ex 25mg | Part B: AZD4547 + Fulvestrant | Part B: Placebo + Fulvestrant | |||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 5/5 (100%) | 5/5 (100%) | 12/12 (100%) | 9/9 (100%) | 5/5 (100%) | 2/4 (50%) | ||||||
| Blood and lymphatic system disorders | ||||||||||||
| ANAEMIA | 0/5 (0%) | 0 | 1/5 (20%) | 1 | 2/12 (16.7%) | 2 | 0/9 (0%) | 0 | 1/5 (20%) | 1 | 1/4 (25%) | 1 |
| LYMPHADENOPATHY | 0/5 (0%) | 0 | 1/5 (20%) | 1 | 0/12 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/4 (0%) | 0 |
| NEUTROPENIA | 0/5 (0%) | 0 | 0/4 (0%) | 0 | 0/12 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 1/4 (25%) | 1 |
| Cardiac disorders | ||||||||||||
| PERICARDIAL EFFUSION | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 1/12 (8.3%) | 1 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/4 (0%) | 0 |
| TACHYCARDIA | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 1/12 (8.3%) | 1 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/4 (0%) | 0 |
| Palpitations | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/12 (0%) | 0 | 0/9 (0%) | 0 | 1/5 (20%) | 1 | 0/4 (0%) | 0 |
| Ear and labyrinth disorders | ||||||||||||
| VERTIGO | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/12 (0%) | 0 | 1/9 (11.1%) | 1 | 0/5 (0%) | 0 | 0/4 (0%) | 0 |
| Eye disorders | ||||||||||||
| CHORIORETINOPATHY | 0/5 (0%) | 0 | 1/5 (20%) | 1 | 0/12 (0%) | 0 | 1/9 (11.1%) | 1 | 0/5 (0%) | 0 | 0/4 (0%) | 0 |
| DETACHMENT OF RETINAL PIGMENT EPITHELIUM | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 3/12 (25%) | 3 | 3/9 (33.3%) | 3 | 0/5 (0%) | 0 | 0/4 (0%) | 0 |
| DRY EYE | 2/5 (40%) | 2 | 1/5 (20%) | 1 | 1/12 (8.3%) | 1 | 0/9 (0%) | 0 | 1/5 (20%) | 1 | 0/4 (0%) | 0 |
| EYE DISCHARGE | 1/5 (20%) | 1 | 0/5 (0%) | 0 | 0/12 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/4 (0%) | 0 |
| EYE DISORDER | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/12 (0%) | 0 | 1/9 (11.1%) | 1 | 0/5 (0%) | 0 | 0/4 (0%) | 0 |
| EYE IRRITATION | 1/5 (20%) | 1 | 0/5 (0%) | 0 | 0/12 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/4 (0%) | 0 |
| EYE PAIN | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/12 (0%) | 0 | 1/9 (11.1%) | 1 | 1/5 (20%) | 1 | 0/4 (0%) | 0 |
| EYELID PAIN | 0/5 (0%) | 0 | 1/5 (20%) | 1 | 0/12 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/4 (0%) | 0 |
| GROWTH OF EYELASHES | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 1/12 (8.3%) | 1 | 1/9 (11.1%) | 1 | 0/5 (0%) | 0 | 0/4 (0%) | 0 |
| KERATITIS | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/12 (0%) | 0 | 1/9 (11.1%) | 1 | 0/5 (0%) | 0 | 0/4 (0%) | 0 |
| LACRIMATION INCREASED | 1/5 (20%) | 1 | 1/5 (20%) | 1 | 1/12 (8.3%) | 1 | 1/9 (11.1%) | 1 | 1/5 (20%) | 1 | 0/4 (0%) | 0 |
| MACULOPATHY | 0/5 (0%) | 0 | 1/5 (20%) | 1 | 0/12 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/4 (0%) | 0 |
| OCULAR DISCOMFORT | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 1/12 (8.3%) | 1 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/4 (0%) | 0 |
| SUBRETINAL FLUID | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 1/12 (8.3%) | 1 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/4 (0%) | 0 |
| ULCERATIVE KERATITIS | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/12 (0%) | 0 | 1/9 (11.1%) | 1 | 0/5 (0%) | 0 | 0/4 (0%) | 0 |
| VISION BLURRED | 2/5 (40%) | 2 | 1/5 (20%) | 1 | 1/12 (8.3%) | 1 | 1/9 (11.1%) | 1 | 1/5 (20%) | 1 | 0/4 (0%) | 0 |
| VISUAL IMPAIRMENT | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 1/12 (8.3%) | 1 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/4 (0%) | 0 |
| VITREOUS FLOATERS | 0/5 (0%) | 0 | 1/5 (20%) | 1 | 0/12 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/4 (0%) | 0 |
| Cataract | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/12 (0%) | 0 | 0/9 (0%) | 0 | 1/5 (20%) | 1 | 0/4 (0%) | 0 |
| Corneal epithelium defect | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/12 (0%) | 0 | 0/9 (0%) | 0 | 1/5 (20%) | 1 | 0/4 (0%) | 0 |
| Ocular hyperaemia | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/12 (0%) | 0 | 0/9 (0%) | 0 | 1/5 (20%) | 1 | 0/4 (0%) | 0 |
| Photophobia | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/12 (0%) | 0 | 0/9 (0%) | 0 | 1/5 (20%) | 1 | 0/4 (0%) | 0 |
| Gastrointestinal disorders | ||||||||||||
| ABDOMINAL DISTENSION | 0/5 (0%) | 0 | 2/5 (40%) | 2 | 0/12 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/4 (0%) | 0 |
| ABDOMINAL MASS | 0/5 (0%) | 0 | 1/5 (20%) | 1 | 0/12 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/4 (0%) | 0 |
| ABDOMINAL PAIN | 1/5 (20%) | 1 | 1/5 (20%) | 1 | 2/12 (16.7%) | 2 | 1/9 (11.1%) | 1 | 0/5 (0%) | 0 | 0/4 (0%) | 0 |
| ABDOMINAL PAIN UPPER | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 1/12 (8.3%) | 1 | 2/9 (22.2%) | 2 | 1/5 (20%) | 1 | 0/4 (0%) | 0 |
| ABDOMINAL TENDERNESS | 0/5 (0%) | 0 | 1/5 (20%) | 1 | 0/12 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/4 (0%) | 0 |
| APHTHOUS STOMATITIS | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/12 (0%) | 0 | 1/9 (11.1%) | 1 | 0/5 (0%) | 0 | 0/4 (0%) | 0 |
| ASCITES | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 1/12 (8.3%) | 1 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/4 (0%) | 0 |
| CONSTIPATION | 1/5 (20%) | 1 | 4/5 (80%) | 4 | 4/12 (33.3%) | 4 | 3/9 (33.3%) | 3 | 1/5 (20%) | 1 | 0/4 (0%) | 0 |
| DIARRHOEA | 3/5 (60%) | 3 | 2/5 (40%) | 2 | 3/12 (25%) | 3 | 3/9 (33.3%) | 3 | 2/5 (40%) | 2 | 0/4 (0%) | 0 |
| DRY MOUTH | 4/5 (80%) | 4 | 3/5 (60%) | 3 | 7/12 (58.3%) | 7 | 5/9 (55.6%) | 5 | 4/5 (80%) | 4 | 0/4 (0%) | 0 |
| DYSPEPSIA | 0/5 (0%) | 0 | 1/5 (20%) | 1 | 0/12 (0%) | 0 | 1/9 (11.1%) | 1 | 1/5 (20%) | 1 | 0/4 (0%) | 0 |
| DYSPHAGIA | 0/5 (0%) | 0 | 1/5 (20%) | 1 | 0/12 (0%) | 0 | 1/9 (11.1%) | 1 | 0/5 (0%) | 0 | 0/4 (0%) | 0 |
| FAECAL INCONTINENCE | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 1/12 (8.3%) | 1 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/4 (0%) | 0 |
| GASTRITIS | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/12 (0%) | 0 | 1/9 (11.1%) | 1 | 0/5 (0%) | 0 | 0/4 (0%) | 0 |
| GASTROOESOPHAGEAL REFLUX DISEASE | 0/5 (0%) | 0 | 1/5 (20%) | 1 | 1/12 (8.3%) | 1 | 1/9 (11.1%) | 1 | 0/5 (0%) | 0 | 0/4 (0%) | 0 |
| GLOSSODYNIA | 0/5 (0%) | 0 | 1/5 (20%) | 1 | 0/12 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/4 (0%) | 0 |
| LIP DRY | 1/5 (20%) | 1 | 0/5 (0%) | 0 | 0/12 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/4 (0%) | 0 |
| MELAENA | 0/5 (0%) | 0 | 1/5 (20%) | 1 | 0/12 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/4 (0%) | 0 |
| MOUTH ULCERATION | 1/5 (20%) | 1 | 0/5 (0%) | 0 | 1/12 (8.3%) | 1 | 0/9 (0%) | 0 | 1/5 (20%) | 1 | 0/4 (0%) | 0 |
| NAUSEA | 1/5 (20%) | 1 | 2/5 (40%) | 2 | 3/12 (25%) | 3 | 5/9 (55.6%) | 5 | 2/5 (40%) | 2 | 1/4 (25%) | 1 |
| OESOPHAGEAL SPASM | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 1/12 (8.3%) | 1 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/4 (0%) | 0 |
| ORAL PAIN | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 1/12 (8.3%) | 1 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/4 (0%) | 0 |
| PARAESTHESIA ORAL | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 1/12 (8.3%) | 1 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/4 (0%) | 0 |
| STOMATITIS | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 4/12 (33.3%) | 4 | 3/9 (33.3%) | 3 | 2/5 (40%) | 2 | 0/4 (0%) | 0 |
| TONGUE DISCOLOURATION | 0/5 (0%) | 0 | 1/5 (20%) | 1 | 0/12 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/4 (0%) | 0 |
| VOMITING | 1/5 (20%) | 1 | 1/5 (20%) | 1 | 1/12 (8.3%) | 1 | 1/9 (11.1%) | 1 | 0/5 (0%) | 0 | 0/4 (0%) | 0 |
| General disorders | ||||||||||||
| ASTHENIA | 0/5 (0%) | 0 | 1/5 (20%) | 1 | 1/12 (8.3%) | 1 | 0/9 (0%) | 0 | 2/5 (40%) | 2 | 0/4 (0%) | 0 |
| CRYING | 0/5 (0%) | 0 | 1/5 (20%) | 1 | 0/12 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/4 (0%) | 0 |
| DEVICE BREAKAGE | 0/5 (0%) | 0 | 1/5 (20%) | 1 | 0/12 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/4 (0%) | 0 |
| FATIGUE | 3/5 (60%) | 3 | 2/5 (40%) | 2 | 4/12 (33.3%) | 4 | 0/9 (0%) | 0 | 1/5 (20%) | 1 | 0/4 (0%) | 0 |
| FIBROSIS | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/12 (0%) | 0 | 1/9 (11.1%) | 1 | 0/5 (0%) | 0 | 0/4 (0%) | 0 |
| GENERAL PHYSICAL HEALTH DETERIORATION | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 1/12 (8.3%) | 1 | 1/9 (11.1%) | 1 | 0/5 (0%) | 0 | 0/4 (0%) | 0 |
| INFLUENZA LIKE ILLNESS | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 1/12 (8.3%) | 1 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/4 (0%) | 0 |
| INJURY ASSOCIATED WITH DEVICE | 0/5 (0%) | 0 | 1/5 (20%) | 1 | 0/12 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/4 (0%) | 0 |
| LOCAL SWELLING | 1/5 (20%) | 1 | 0/5 (0%) | 0 | 1/12 (8.3%) | 1 | 1/9 (11.1%) | 1 | 0/5 (0%) | 0 | 0/4 (0%) | 0 |
| OEDEMA | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/12 (0%) | 0 | 1/9 (11.1%) | 1 | 0/5 (0%) | 0 | 0/4 (0%) | 0 |
| OEDEMA PERIPHERAL | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 1/12 (8.3%) | 1 | 1/9 (11.1%) | 1 | 0/5 (0%) | 0 | 0/4 (0%) | 0 |
| PYREXIA | 1/5 (20%) | 1 | 0/5 (0%) | 0 | 1/12 (8.3%) | 1 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/4 (0%) | 0 |
| Gait disturbance | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/12 (0%) | 0 | 0/9 (0%) | 0 | 1/5 (20%) | 1 | 0/4 (0%) | 0 |
| Induration | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/12 (0%) | 0 | 0/9 (0%) | 0 | 1/5 (20%) | 1 | 0/4 (0%) | 0 |
| Inflammation | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/12 (0%) | 0 | 0/9 (0%) | 0 | 1/5 (20%) | 1 | 0/4 (0%) | 0 |
| Injection site rash | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/12 (0%) | 0 | 0/9 (0%) | 0 | 1/5 (20%) | 1 | 0/4 (0%) | 0 |
| Mucosal inflammation | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/12 (0%) | 0 | 0/9 (0%) | 0 | 2/5 (40%) | 2 | 0/4 (0%) | 0 |
| Feeling hot | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/12 (0%) | 0 | 0/9 (0%) | 0 | 1/5 (20%) | 1 | 0/4 (0%) | 0 |
| Hepatobiliary disorders | ||||||||||||
| CHOLELITHIASIS | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 1/12 (8.3%) | 1 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/4 (0%) | 0 |
| Immune system disorders | ||||||||||||
| SEASONAL ALLERGY | 0/5 (0%) | 0 | 1/5 (20%) | 1 | 0/12 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/4 (0%) | 0 |
| Infections and infestations | ||||||||||||
| CELLULITIS | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 1/12 (8.3%) | 1 | 0/9 (0%) | 0 | 1/5 (20%) | 1 | 0/4 (0%) | 0 |
| CONJUNCTIVITIS | 1/5 (20%) | 1 | 0/5 (0%) | 0 | 0/12 (0%) | 0 | 1/9 (11.1%) | 1 | 0/5 (0%) | 0 | 0/4 (0%) | 0 |
| CYSTITIS | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 1/12 (8.3%) | 1 | 1/9 (11.1%) | 1 | 1/5 (20%) | 1 | 0/4 (0%) | 0 |
| GINGIVITIS | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 1/12 (8.3%) | 1 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/4 (0%) | 0 |
| INFLUENZA | 1/5 (20%) | 1 | 0/5 (0%) | 0 | 0/12 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/4 (0%) | 0 |
| LARYNGITIS | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 2/12 (16.7%) | 2 | 0/9 (0%) | 0 | 1/5 (20%) | 1 | 0/4 (0%) | 0 |
| LOCALISED INFECTION | 1/5 (20%) | 1 | 0/5 (0%) | 0 | 0/12 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/4 (0%) | 0 |
| LOWER RESPIRATORY TRACT INFECTION | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/12 (0%) | 0 | 1/9 (11.1%) | 1 | 0/5 (0%) | 0 | 0/4 (0%) | 0 |
| LOWER RESPIRATORY TRACT INFECTION VIRAL | 1/5 (20%) | 1 | 1/5 (20%) | 1 | 2/12 (16.7%) | 2 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/4 (0%) | 0 |
| LYMPHANGITIS | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 1/12 (8.3%) | 1 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/4 (0%) | 0 |
| MASTITIS | 1/5 (20%) | 1 | 0/5 (0%) | 0 | 0/12 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/4 (0%) | 0 |
| NAIL INFECTION | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/12 (0%) | 0 | 1/9 (11.1%) | 1 | 0/5 (0%) | 0 | 0/4 (0%) | 0 |
| OESOPHAGEAL CANDIDIASIS | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/12 (0%) | 0 | 1/9 (11.1%) | 1 | 0/5 (0%) | 0 | 0/4 (0%) | 0 |
| ORAL CANDIDIASIS | 1/5 (20%) | 1 | 0/5 (0%) | 0 | 1/12 (8.3%) | 1 | 1/9 (11.1%) | 1 | 0/5 (0%) | 0 | 0/4 (0%) | 0 |
| PARONYCHIA | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/12 (0%) | 0 | 1/9 (11.1%) | 1 | 1/5 (20%) | 1 | 0/4 (0%) | 0 |
| PHARYNGITIS | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/12 (0%) | 0 | 1/9 (11.1%) | 1 | 0/5 (0%) | 0 | 0/4 (0%) | 0 |
| SINUSITIS | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 1/12 (8.3%) | 1 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/4 (0%) | 0 |
| URINARY TRACT INFECTION | 0/5 (0%) | 0 | 1/5 (20%) | 1 | 3/12 (25%) | 3 | 1/9 (11.1%) | 1 | 2/5 (40%) | 2 | 0/4 (0%) | 0 |
| URINARY TRACT INFECTION BACTERIAL | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 1/12 (8.3%) | 1 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/4 (0%) | 0 |
| URINARY TRACT INFECTION FUNGAL | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 1/12 (8.3%) | 1 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/4 (0%) | 0 |
| VARICELLA | 1/5 (20%) | 1 | 0/5 (0%) | 0 | 0/12 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/4 (0%) | 0 |
| VIRAL UPPER RESPIRATORY TRACT INFECTION | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/12 (0%) | 0 | 1/9 (11.1%) | 1 | 0/5 (0%) | 0 | 0/4 (0%) | 0 |
| VULVOVAGINAL CANDIDIASIS | 0/5 (0%) | 0 | 1/5 (20%) | 1 | 0/12 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/4 (0%) | 0 |
| Herpes zoster | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/12 (0%) | 0 | 0/9 (0%) | 0 | 1/5 (20%) | 1 | 0/4 (0%) | 0 |
| Nasopharyngitis | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/12 (0%) | 0 | 0/9 (0%) | 0 | 1/5 (20%) | 1 | 0/4 (0%) | 0 |
| Oropharyngeal candidiasis | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/12 (0%) | 0 | 0/9 (0%) | 0 | 1/5 (20%) | 1 | 0/4 (0%) | 0 |
| Post viral fatigue syndrome | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/12 (0%) | 0 | 0/9 (0%) | 0 | 1/5 (20%) | 1 | 0/4 (0%) | 0 |
| Rash pustular | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/12 (0%) | 0 | 0/9 (0%) | 0 | 1/5 (20%) | 1 | 0/4 (0%) | 0 |
| Injury, poisoning and procedural complications | ||||||||||||
| ARTHROPOD BITE | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 1/12 (8.3%) | 1 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/4 (0%) | 0 |
| CONTUSION | 1/5 (20%) | 1 | 1/5 (20%) | 1 | 0/12 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/4 (0%) | 0 |
| FALL | 0/5 (0%) | 0 | 1/5 (20%) | 1 | 0/12 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/4 (0%) | 0 |
| INFUSION RELATED REACTION | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/12 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/4 (0%) | 0 |
| JOINT INJURY | 0/5 (0%) | 0 | 1/5 (20%) | 1 | 0/12 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/4 (0%) | 0 |
| LACERATION | 0/5 (0%) | 0 | 1/5 (20%) | 1 | 0/12 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/4 (0%) | 0 |
| TRAUMATIC HAEMATOMA | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/12 (0%) | 0 | 1/9 (11.1%) | 1 | 0/5 (0%) | 0 | 0/4 (0%) | 0 |
| Arthropod sting | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/12 (0%) | 0 | 0/9 (0%) | 0 | 1/5 (20%) | 1 | 0/4 (0%) | 0 |
| Investigations | ||||||||||||
| ALANINE AMINOTRANSFERASE INCREASED | 1/5 (20%) | 1 | 0/5 (0%) | 0 | 0/12 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/4 (0%) | 0 |
| ASPARTATE AMINOTRANSFERASE INCREASED | 1/5 (20%) | 1 | 1/5 (20%) | 1 | 0/12 (0%) | 0 | 1/9 (11.1%) | 1 | 0/5 (0%) | 0 | 0/4 (0%) | 0 |
| BLOOD ALKALINE PHOSPHATASE INCREASED | 1/5 (20%) | 1 | 0/5 (0%) | 0 | 0/12 (0%) | 0 | 1/9 (11.1%) | 1 | 0/5 (0%) | 0 | 0/4 (0%) | 0 |
| BLOOD CREATININE INCREASED | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 1/12 (8.3%) | 1 | 1/9 (11.1%) | 1 | 0/5 (0%) | 0 | 1/4 (25%) | 1 |
| BLOOD GLUCOSE INCREASED | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 1/12 (8.3%) | 1 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/4 (0%) | 0 |
| BLOOD IRON DECREASED | 0/5 (0%) | 0 | 1/5 (20%) | 1 | 0/12 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/4 (0%) | 0 |
| BLOOD PHOSPHORUS INCREASED | 1/5 (20%) | 1 | 0/5 (0%) | 0 | 3/12 (25%) | 3 | 1/9 (11.1%) | 1 | 0/5 (0%) | 0 | 0/4 (0%) | 0 |
| BODY TEMPERATURE INCREASED | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 1/12 (8.3%) | 1 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/4 (0%) | 0 |
| C-REACTIVE PROTEIN INCREASED | 1/5 (20%) | 1 | 1/5 (20%) | 1 | 0/12 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/4 (0%) | 0 |
| CARDIAC ENZYMES INCREASED | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 1/12 (8.3%) | 1 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/4 (0%) | 0 |
| COLD AGGLUTININS POSITIVE | 1/5 (20%) | 1 | 0/5 (0%) | 0 | 0/12 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/4 (0%) | 0 |
| ELECTROCARDIOGRAM T WAVE ABNORMAL | 0/5 (0%) | 0 | 1/5 (20%) | 1 | 0/12 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/4 (0%) | 0 |
| GAMMA-GLUTAMYLTRANSFERASE INCREASED | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/12 (0%) | 0 | 1/9 (11.1%) | 1 | 0/5 (0%) | 0 | 0/4 (0%) | 0 |
| INSPIRATORY CAPACITY DECREASED | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 1/12 (8.3%) | 1 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/4 (0%) | 0 |
| NEUTROPHIL COUNT INCREASED | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 1/12 (8.3%) | 1 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/4 (0%) | 0 |
| OXYGEN SATURATION DECREASED | 0/5 (0%) | 0 | 1/5 (20%) | 1 | 1/12 (8.3%) | 1 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/4 (0%) | 0 |
| TROPONIN T INCREASED | 1/5 (20%) | 1 | 0/5 (0%) | 0 | 0/12 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/4 (0%) | 0 |
| WEIGHT DECREASED | 1/5 (20%) | 1 | 0/5 (0%) | 0 | 0/12 (0%) | 0 | 1/9 (11.1%) | 1 | 0/5 (0%) | 0 | 0/4 (0%) | 0 |
| Ejection fraction decreased | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/12 (0%) | 0 | 0/9 (0%) | 0 | 1/5 (20%) | 1 | 0/4 (0%) | 0 |
| Metabolism and nutrition disorders | ||||||||||||
| DECREASED APPETITE | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 1/12 (8.3%) | 1 | 4/9 (44.4%) | 4 | 1/5 (20%) | 1 | 0/4 (0%) | 0 |
| DEHYDRATION | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 2/12 (16.7%) | 2 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/4 (0%) | 0 |
| HYPERCALCAEMIA | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/12 (0%) | 0 | 1/9 (11.1%) | 1 | 0/5 (0%) | 0 | 1/4 (25%) | 1 |
| HYPERGLYCAEMIA | 1/5 (20%) | 1 | 0/5 (0%) | 0 | 0/12 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/4 (0%) | 0 |
| HYPERPHOSPHATAEMIA | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 1/12 (8.3%) | 1 | 3/9 (33.3%) | 3 | 0/5 (0%) | 0 | 0/4 (0%) | 0 |
| HYPONATRAEMIA | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 1/12 (8.3%) | 1 | 1/9 (11.1%) | 1 | 0/5 (0%) | 0 | 0/4 (0%) | 0 |
| Musculoskeletal and connective tissue disorders | ||||||||||||
| ARTHRALGIA | 2/5 (40%) | 2 | 1/5 (20%) | 1 | 3/12 (25%) | 3 | 1/9 (11.1%) | 1 | 1/5 (20%) | 1 | 0/4 (0%) | 0 |
| ARTHRITIS | 0/5 (0%) | 0 | 1/5 (20%) | 1 | 1/12 (8.3%) | 1 | 0/9 (0%) | 0 | 1/5 (20%) | 1 | 0/4 (0%) | 0 |
| JOINT EFFUSION | 1/5 (20%) | 1 | 0/5 (0%) | 0 | 0/12 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/4 (0%) | 0 |
| JOINT SWELLING | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 1/12 (8.3%) | 1 | 1/9 (11.1%) | 1 | 0/5 (0%) | 0 | 0/4 (0%) | 0 |
| MUSCLE SPASMS | 0/5 (0%) | 0 | 1/5 (20%) | 1 | 1/12 (8.3%) | 1 | 1/9 (11.1%) | 1 | 1/5 (20%) | 1 | 0/4 (0%) | 0 |
| MUSCULOSKELETAL CHEST PAIN | 1/5 (20%) | 1 | 0/5 (0%) | 0 | 0/12 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/4 (0%) | 0 |
| MUSCULOSKELETAL PAIN | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/12 (0%) | 0 | 1/9 (11.1%) | 1 | 1/5 (20%) | 1 | 0/4 (0%) | 0 |
| MYALGIA | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 3/12 (25%) | 3 | 0/9 (0%) | 0 | 1/5 (20%) | 1 | 0/4 (0%) | 0 |
| NECK PAIN | 0/5 (0%) | 0 | 1/5 (20%) | 1 | 2/12 (16.7%) | 2 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/4 (0%) | 0 |
| PAIN IN EXTREMITY | 0/5 (0%) | 0 | 1/5 (20%) | 1 | 2/12 (16.7%) | 2 | 2/9 (22.2%) | 2 | 1/5 (20%) | 1 | 0/4 (0%) | 0 |
| PAIN IN JAW | 0/5 (0%) | 0 | 1/5 (20%) | 1 | 0/12 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/4 (0%) | 0 |
| Back pain | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/12 (0%) | 0 | 0/9 (0%) | 0 | 1/5 (20%) | 1 | 0/4 (0%) | 0 |
| Bursitis | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/12 (0%) | 0 | 0/9 (0%) | 0 | 1/5 (20%) | 1 | 0/4 (0%) | 0 |
| Joint stiffness | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/12 (0%) | 0 | 0/9 (0%) | 0 | 1/5 (20%) | 1 | 0/4 (0%) | 0 |
| Psoriatic arthropathy | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/12 (0%) | 0 | 0/9 (0%) | 0 | 1/5 (20%) | 1 | 0/4 (0%) | 0 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||||||||
| BREAST CANCER METASTATIC | 0/5 (0%) | 0 | 1/5 (20%) | 1 | 0/12 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/4 (0%) | 0 |
| METASTATIC PAIN | 0/5 (0%) | 0 | 1/5 (20%) | 1 | 0/12 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/4 (0%) | 0 |
| NEURILEMMOMA BENIGN | 1/5 (20%) | 1 | 0/5 (0%) | 0 | 0/12 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/4 (0%) | 0 |
| TUMOUR PAIN | 1/5 (20%) | 1 | 0/5 (0%) | 0 | 0/12 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/4 (0%) | 0 |
| Nervous system disorders | ||||||||||||
| AGEUSIA | 1/5 (20%) | 1 | 0/5 (0%) | 0 | 0/12 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/4 (0%) | 0 |
| APHASIA | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 1/12 (8.3%) | 1 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/4 (0%) | 0 |
| DYSGEUSIA | 2/5 (40%) | 2 | 2/5 (40%) | 2 | 6/12 (50%) | 6 | 6/9 (66.7%) | 6 | 0/5 (0%) | 0 | 0/4 (0%) | 0 |
| HEADACHE | 1/5 (20%) | 1 | 1/5 (20%) | 1 | 3/12 (25%) | 3 | 2/9 (22.2%) | 2 | 1/5 (20%) | 1 | 0/4 (0%) | 0 |
| HYPOAESTHESIA | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/12 (0%) | 0 | 1/9 (11.1%) | 1 | 0/5 (0%) | 0 | 0/4 (0%) | 0 |
| HYPOKINESIA | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 1/12 (8.3%) | 1 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/4 (0%) | 0 |
| LETHARGY | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/12 (0%) | 0 | 2/9 (22.2%) | 2 | 0/5 (0%) | 0 | 0/4 (0%) | 0 |
| MYOCLONUS | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 1/12 (8.3%) | 1 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/4 (0%) | 0 |
| NEURALGIA | 1/5 (20%) | 1 | 0/5 (0%) | 0 | 0/12 (0%) | 0 | 1/9 (11.1%) | 1 | 0/5 (0%) | 0 | 0/4 (0%) | 0 |
| NEUROPATHY PERIPHERAL | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 1/12 (8.3%) | 1 | 1/9 (11.1%) | 1 | 0/5 (0%) | 0 | 0/4 (0%) | 0 |
| PARAESTHESIA | 0/5 (0%) | 0 | 1/5 (20%) | 1 | 3/12 (25%) | 3 | 1/9 (11.1%) | 1 | 1/5 (20%) | 1 | 0/4 (0%) | 0 |
| PERIPHERAL SENSORY NEUROPATHY | 1/5 (20%) | 1 | 0/5 (0%) | 0 | 0/12 (0%) | 0 | 1/9 (11.1%) | 1 | 0/5 (0%) | 0 | 0/4 (0%) | 0 |
| SCIATICA | 0/5 (0%) | 0 | 1/5 (20%) | 1 | 0/12 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/4 (0%) | 0 |
| TREMOR | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 1/12 (8.3%) | 1 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/4 (0%) | 0 |
| Burning sensation | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/12 (0%) | 0 | 0/9 (0%) | 0 | 1/5 (20%) | 1 | 0/4 (0%) | 0 |
| Dizziness | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/12 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 1/4 (25%) | 1 |
| Psychiatric disorders | ||||||||||||
| DEPRESSED MOOD | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 1/12 (8.3%) | 1 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/4 (0%) | 0 |
| DEPRESSION | 1/5 (20%) | 1 | 1/5 (20%) | 1 | 0/12 (0%) | 0 | 1/9 (11.1%) | 1 | 0/5 (0%) | 0 | 0/4 (0%) | 0 |
| DEREALISATION | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/12 (0%) | 0 | 1/9 (11.1%) | 1 | 0/5 (0%) | 0 | 0/4 (0%) | 0 |
| INSOMNIA | 0/5 (0%) | 0 | 1/5 (20%) | 1 | 2/12 (16.7%) | 2 | 1/9 (11.1%) | 1 | 0/5 (0%) | 0 | 0/4 (0%) | 0 |
| SLEEP DISORDER | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 1/12 (8.3%) | 1 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/4 (0%) | 0 |
| Renal and urinary disorders | ||||||||||||
| HYDRONEPHROSIS | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 1/12 (8.3%) | 1 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/4 (0%) | 0 |
| NEPHROLITHIASIS | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 1/12 (8.3%) | 1 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/4 (0%) | 0 |
| PROTEINURIA | 1/5 (20%) | 1 | 0/5 (0%) | 0 | 0/12 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/4 (0%) | 0 |
| URINARY RETENTION | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 1/12 (8.3%) | 1 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/4 (0%) | 0 |
| URINARY TRACT OBSTRUCTION | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 1/12 (8.3%) | 1 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/4 (0%) | 0 |
| Reproductive system and breast disorders | ||||||||||||
| BREAST DISORDER | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 1/12 (8.3%) | 1 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/4 (0%) | 0 |
| BREAST PAIN | 1/5 (20%) | 1 | 0/5 (0%) | 0 | 1/12 (8.3%) | 1 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/4 (0%) | 0 |
| VULVOVAGINAL DRYNESS | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 1/12 (8.3%) | 1 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/4 (0%) | 0 |
| Respiratory, thoracic and mediastinal disorders | ||||||||||||
| ASTHMA | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 1/12 (8.3%) | 1 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/4 (0%) | 0 |
| COUGH | 1/5 (20%) | 1 | 1/5 (20%) | 1 | 1/12 (8.3%) | 1 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/4 (0%) | 0 |
| DRY THROAT | 1/5 (20%) | 1 | 1/5 (20%) | 1 | 1/12 (8.3%) | 1 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/4 (0%) | 0 |
| DYSPHONIA | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 1/12 (8.3%) | 1 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/4 (0%) | 0 |
| DYSPNOEA | 0/5 (0%) | 0 | 1/5 (20%) | 1 | 2/12 (16.7%) | 2 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/4 (0%) | 0 |
| EPISTAXIS | 3/5 (60%) | 3 | 2/5 (40%) | 2 | 2/12 (16.7%) | 2 | 2/9 (22.2%) | 2 | 0/5 (0%) | 0 | 0/4 (0%) | 0 |
| LUNG CONSOLIDATION | 0/5 (0%) | 0 | 1/5 (20%) | 1 | 0/12 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/4 (0%) | 0 |
| NASAL DISCOMFORT | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 1/12 (8.3%) | 1 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/4 (0%) | 0 |
| NASAL DRYNESS | 1/5 (20%) | 1 | 1/5 (20%) | 1 | 0/12 (0%) | 0 | 1/9 (11.1%) | 1 | 0/5 (0%) | 0 | 0/4 (0%) | 0 |
| NASAL INFLAMMATION | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 1/12 (8.3%) | 1 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/4 (0%) | 0 |
| OROPHARYNGEAL PAIN | 0/5 (0%) | 0 | 1/5 (20%) | 1 | 1/12 (8.3%) | 1 | 1/9 (11.1%) | 1 | 0/5 (0%) | 0 | 1/4 (25%) | 1 |
| PLEURAL EFFUSION | 0/5 (0%) | 0 | 1/5 (20%) | 1 | 1/12 (8.3%) | 1 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/4 (0%) | 0 |
| PLEURITIC PAIN | 0/5 (0%) | 0 | 1/5 (20%) | 1 | 0/12 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/4 (0%) | 0 |
| PRODUCTIVE COUGH | 1/5 (20%) | 1 | 0/5 (0%) | 0 | 0/12 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/4 (0%) | 0 |
| RALES | 1/5 (20%) | 1 | 0/5 (0%) | 0 | 0/12 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/4 (0%) | 0 |
| RHINALGIA | 0/5 (0%) | 0 | 1/5 (20%) | 1 | 0/12 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/4 (0%) | 0 |
| RHINORRHOEA | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/12 (0%) | 0 | 1/9 (11.1%) | 1 | 0/5 (0%) | 0 | 0/4 (0%) | 0 |
| Skin and subcutaneous tissue disorders | ||||||||||||
| ALOPECIA | 5/5 (100%) | 5 | 3/5 (60%) | 3 | 6/12 (50%) | 6 | 5/9 (55.6%) | 5 | 2/5 (40%) | 2 | 0/4 (0%) | 0 |
| BLISTER | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 2/12 (16.7%) | 2 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/4 (0%) | 0 |
| DRY SKIN | 2/5 (40%) | 2 | 1/5 (20%) | 1 | 5/12 (41.7%) | 5 | 3/9 (33.3%) | 3 | 2/5 (40%) | 2 | 0/4 (0%) | 0 |
| ERYTHEMA | 2/5 (40%) | 2 | 0/5 (0%) | 0 | 0/12 (0%) | 0 | 1/9 (11.1%) | 1 | 1/5 (20%) | 1 | 0/4 (0%) | 0 |
| MADAROSIS | 0/5 (0%) | 0 | 1/5 (20%) | 1 | 0/12 (0%) | 0 | 1/9 (11.1%) | 1 | 0/5 (0%) | 0 | 0/4 (0%) | 0 |
| NAIL BED BLEEDING | 1/5 (20%) | 1 | 0/5 (0%) | 0 | 0/12 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/4 (0%) | 0 |
| NAIL DISCOLOURATION | 1/5 (20%) | 1 | 0/5 (0%) | 0 | 0/12 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/4 (0%) | 0 |
| NAIL DISORDER | 1/5 (20%) | 1 | 0/5 (0%) | 0 | 4/12 (33.3%) | 4 | 4/9 (44.4%) | 4 | 1/5 (20%) | 1 | 0/4 (0%) | 0 |
| NAIL DYSTROPHY | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 1/12 (8.3%) | 1 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/4 (0%) | 0 |
| NIGHT SWEATS | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 1/12 (8.3%) | 1 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/4 (0%) | 0 |
| ONYCHALGIA | 2/5 (40%) | 2 | 0/5 (0%) | 0 | 0/12 (0%) | 0 | 2/9 (22.2%) | 2 | 0/5 (0%) | 0 | 0/4 (0%) | 0 |
| ONYCHOLYSIS | 1/5 (20%) | 1 | 0/5 (0%) | 0 | 0/12 (0%) | 0 | 1/9 (11.1%) | 1 | 1/5 (20%) | 1 | 0/4 (0%) | 0 |
| PAIN OF SKIN | 1/5 (20%) | 1 | 0/5 (0%) | 0 | 0/12 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/4 (0%) | 0 |
| PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 2/12 (16.7%) | 2 | 3/9 (33.3%) | 3 | 2/5 (40%) | 2 | 0/4 (0%) | 0 |
| PAPULE | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/12 (0%) | 0 | 1/9 (11.1%) | 1 | 0/5 (0%) | 0 | 0/4 (0%) | 0 |
| RASH | 1/5 (20%) | 1 | 0/5 (0%) | 0 | 1/12 (8.3%) | 1 | 2/9 (22.2%) | 2 | 0/5 (0%) | 0 | 0/4 (0%) | 0 |
| RASH ERYTHEMATOUS | 1/5 (20%) | 1 | 0/5 (0%) | 0 | 2/12 (16.7%) | 2 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/4 (0%) | 0 |
| RASH MACULAR | 1/5 (20%) | 1 | 0/5 (0%) | 0 | 0/12 (0%) | 0 | 1/9 (11.1%) | 1 | 0/5 (0%) | 0 | 0/4 (0%) | 0 |
| RASH PRURITIC | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 1/12 (8.3%) | 1 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/4 (0%) | 0 |
| SKIN DISCOLOURATION | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 1/12 (8.3%) | 1 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/4 (0%) | 0 |
| SKIN FISSURES | 1/5 (20%) | 1 | 0/5 (0%) | 0 | 0/12 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/4 (0%) | 0 |
| SKIN HAEMORRHAGE | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/12 (0%) | 0 | 1/9 (11.1%) | 1 | 0/5 (0%) | 0 | 0/4 (0%) | 0 |
| SKIN ULCER | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/12 (0%) | 0 | 1/9 (11.1%) | 1 | 0/5 (0%) | 0 | 0/4 (0%) | 0 |
| SWELLING FACE | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 1/12 (8.3%) | 1 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/4 (0%) | 0 |
| Dermatitis contact | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/12 (0%) | 0 | 0/9 (0%) | 0 | 1/5 (20%) | 1 | 0/4 (0%) | 0 |
| Pruritus | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/12 (0%) | 0 | 0/9 (0%) | 0 | 1/5 (20%) | 1 | 0/4 (0%) | 0 |
| Vascular disorders | ||||||||||||
| HOT FLUSH | 1/5 (20%) | 1 | 0/5 (0%) | 0 | 1/12 (8.3%) | 1 | 2/9 (22.2%) | 2 | 1/5 (20%) | 1 | 0/4 (0%) | 0 |
| HYPERTENSION | 1/5 (20%) | 1 | 0/5 (0%) | 0 | 0/12 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/4 (0%) | 0 |
| HYPOTENSION | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 1/12 (8.3%) | 1 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/4 (0%) | 0 |
| LYMPHOEDEMA | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 1/12 (8.3%) | 1 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/4 (0%) | 0 |
| PALLOR | 1/5 (20%) | 1 | 0/5 (0%) | 0 | 0/12 (0%) | 0 | 0/9 (0%) | 0 | 0/5 (0%) | 0 | 0/4 (0%) | 0 |
| Phlebitis | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/12 (0%) | 0 | 0/9 (0%) | 0 | 1/5 (20%) | 1 | 0/4 (0%) | 0 |
Limitations/Caveats
Enrolment to the Part B was terminated on 27 March 2014. Slow recruitment led to concerns that enrolment would not be completed in a realistic timeframe. This led to a business decision to terminate the enrolment.
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
Results Point of Contact
| Name/Title | Richard Mather |
|---|---|
| Organization | Astrazeneca |
| Phone | +44 1763 263593 |
| ClinicalTrialTransparency@astrazeneca.com |
Responsible Party:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01202591
Other Study ID Numbers:
- D2610C00003
- 2010-021220-10
First Posted:
Sep 16, 2010
Last Update Posted:
Feb 11, 2016
Last Verified:
Jan 1, 2016