This is an HTML version of an attachment to the Freedom of Information request 'Information related to the NCE approval of tafenoquine succinate'.


Document 1
Case Line Listing
Cases Count: 32
Report 
Onset 
Onset 
Case No. Date
Date
State
Sex Age Outcome
Medicine
Time
Reaction
163217
29/03/2001
M
25
Chloroquine -Suspected
Infection parasitic
Tafenoquine CT -Suspected
Chloroquine -Other drug
Doxycycline Hyclate -Other drug
Primaquine Phosphate -Other drug
Quinine -Other drug
163375
05/04/2001
U
??
Tafenoquine CT -Suspected
Visual impairment
163376
05/04/2001
U
??
Tafenoquine CT -Suspected
Visual impairment
164025
30/04/2001
U
??
Tafenoquine CT -Suspected
Visual impairment
164026
30/04/2001
U
??
Tafenoquine CT -Suspected
Visual impairment
164339
07/05/2001
U
??
Tafenoquine CT -Suspected
Visual impairment
377817
22/03/2016
F
??
Lariam (Mefloquine Hydrochloride) -Suspected
Completed suicide
Tafenoquine CT -Suspected
392376
27/07/2016
M
28
Tafenoquine CT -Suspected
Depression
Pain
Post-traumatic stress diso
393834
23/08/2016
M
99
Mefloquine Hydrochloride -Suspected
Completed suicide
Tafenoquine CT -Suspected
396130
29/09/2016
M
??
Lariam (Mefloquine Hydrochloride) -Suspected
Brain injury
Tafenoquine CT -Suspected
Toxicity to various agents
403837
18/02/2017
M
30
Tafenoquine CT -Suspected
Amnesia
Depression
Anxiety
PWTRAN01
Report Printed :
10/04/2018 10:23
Page 1 of 6


Case Line Listing
Cases Count: 32
Report 
Onset 
Onset 
Case No. Date
Date
State
Sex Age Outcome
Medicine
Time
Reaction
403839
18/02/2017
M
29
Tafenoquine CT -Suspected
Malaria
Encephalopathy
Drug ineffective
403840
18/02/2017
M
23
Tafenoquine CT -Suspected
Amnesia
Headache
Depression
Nausea
Insomnia
Abdominal pain upper
Tinnitus
Post-traumatic stress diso
403842
18/02/2017
Unknown M
39
Tafenoquine CT -Suspected
Anxiety
Sleep terror
Irritability
Anger
Hallucination
Post-traumatic stress diso
403846
19/02/2017
M
39
Tafenoquine CT -Suspected
Aggression
Nausea
Anger
Abdominal pain upper
Syncope
403848
18/02/2017
M
20
Tafenoquine CT -Suspected
Blood calcium increased
Insomnia
Liver function test abnorm
Mental disorder
Anger
PWTRAN01
Report Printed :
10/04/2018 10:23
Page 2 of 6


Case Line Listing
Cases Count: 32
Report 
Onset 
Onset 
Case No. Date
Date
State
Sex Age Outcome
Medicine
Time
Reaction
403849
18/02/2017
M
44
Tafenoquine CT -Suspected
4
Headache
Doxycycline -Other drug
Depression
Nausea
Adjustment disorder
Loss of consciousness
403850
19/02/2017
M
39
Tafenoquine CT -Suspected
Aggression
Anxiety
Depression
Nausea
Abnormal dreams
403852
19/02/2017
M
46
Tafenoquine CT -Suspected
5642
Depression
Anxiety
Vertigo
Post-traumatic stress diso
403853
19/02/2017
M
40
Tafenoquine CT -Suspected
Mental disorder
403854
19/02/2017
M
34
Tafenoquine CT -Suspected
Anxiety
Depression
Anger
Alcoholism
403858
19/02/2017
M
25
Tafenoquine CT -Suspected
Anxiety
Depression
Aggression
Anger
Emotional poverty
Confusional state
403921
20/02/2017
M
25
Tafenoquine CT -Suspected
60
Anxiety
Panic attack
Anger
Nightmare
Post-traumatic stress diso
PWTRAN01
Report Printed :
10/04/2018 10:23
Page 3 of 6


Case Line Listing
Cases Count: 32
Report 
Onset 
Onset 
Case No. Date
Date
State
Sex Age Outcome
Medicine
Time
Reaction
403922
20/02/2017
1
M
28
Tafenoquine CT -Suspected
0
Amnesia
Anxiety
Aggression
Paranoia
Dizziness
Abdominal pain
Abnormal dreams
Vertigo
Tinnitus
Mood swings
Hallucination
Diarrhoea
Confusional state
404011
21/02/2017
M
23
Mefloquine Hydrochloride -Suspected
98
Abnormal behaviour
Tafenoquine CT -Suspected
Coordination abnormal
Anxiety
Depression
Vision blurred
Sleep disorder
Gastrooesophageal reflux
disease
Tinnitus
Suicidal ideation
Photophobia
Confusional state
Irritable bowel syndrome
PWTRAN01
Report Printed :
10/04/2018 10:23
Page 4 of 6


Case Line Listing
Cases Count: 32
Report 
Onset 
Onset 
Case No. Date
Date
State
Sex Age Outcome
Medicine
Time
Reaction
404026
21/02/2017
M
43
Tafenoquine CT -Suspected
Pain
Memory impairment
Disturbance in attention
Dizziness
Fatigue
Slow response to stimuli
Post-traumatic stress diso
Hypoacusis
Pericarditis
404214
23/02/2017
M
37
Tafenoquine CT -Suspected
Anxiety
Calamine -Other drug
Depression
Dissociation
Chlorsig (Chloramphenicol) -Other drug
Disturbance in attention
Symbicort (Budesonide-Formoterol Fumarate
Panic attack
Dihydrate) -Other drug
Agitation
Tineafax Ointment (Tolnaftate) -Other drug
Vertigo
Tinnitus
Hallucination
Mood swings
Suicidal ideation
Muscle twitching
Confusional state
404422
28/02/2017
M
??
Mefloquine Hydrochloride -Suspected
Completed suicide
Tafenoquine CT -Suspected
411237
06/06/2017
M
30
Mefloquine Hydrochloride -Suspected
Nightmare
Tafenoquine CT -Suspected
Condition aggravated
414013
12/07/2017
M
31
Tafenoquine CT -Suspected
Abnormal behaviour
Anxiety
Depression
Rash
Suicidal ideation
PWTRAN01
Report Printed :
10/04/2018 10:23
Page 5 of 6


Case Line Listing
Cases Count: 32
Report 
Onset 
Onset 
Case No. Date
Date
State
Sex Age Outcome
Medicine
Time
Reaction
417864
11/09/2017
M
41
Unknown
Lariam (Mefloquine Hydrochloride) -Suspected
Central nervous system le
Tafenoquine CT -Suspected
Haematotoxicity
424376
21/12/2017
M
??
Unknown
Tafenoquine CT -Suspected
Depression
Anxiety
Brain injury
Alcohol abuse
Suicidal ideation
Mood swings
Post-traumatic stress diso
Selection Parameters :   Date Range: 01/01/1960 To 31/12/2059  Medicine Status: Clinical trials, General marketing, Individual patient use, Intensive monitoring, Overdose, Post marketing surveillance, Special
access scheme  Medicine Names: Tafenoquine CT
PWTRAN01
Report Printed :
10/04/2018 10:23
Page 6 of 6